Devices › Implant, endosseous, root-form

Device brand name · Endosseous dental implant

TLC SP, ?3.75mm RT, SLActive? 8mm RXD: medical device reports filed with FDA

308 reports name it, 2024–2026. Manufacturer given most often on reports: Institut Straumann. Product code DZE.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

308
device reports naming the brand: 0% of all MAUDE reports · about 128 a year; 193
reports, 12 months to August 2026: 101 in the 12 months before; 0%
classified as malfunction: 0.8% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

308 medical device reports received by FDA name the brand "TLC SP, ?3.75mm RT, SLActive? 8mm RXD" (endosseous dental implant); the manufacturer given most often on reports is Institut Straumann; received from February 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

193 reports arrived in the 12 months to August 2026, up 91% from 101 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (100%); across all implant, endosseous, root-form reports (product code DZE) death is recorded in 0% and malfunction in 0.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to osseointegrate (78.9%), loss of osseointegration (13.3%) and difficult to insert (1.3%). The patient problems coded most often are fibrosis, pain and inflammation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury100%308

Malfunction0%0

Other0%0

Not given0%0

Who filed the report

Manufacturer report93.5%288

Voluntary report0%0

User facility report0%0

Distributor report6.5%20

Not given0%0

Grey bar: all 3,924,241 reports carrying product code DZE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Failure to osseointegrate	243	78.9%	62.8%
Loss of osseointegration	41	13.3%	22.4%
Difficult to insertthe device was hard to insert	4	1.3%	0.4%
Separation failure	2	0.6%	0.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Fibrosis	96	31.2%
Painpain, site not specified	56	18.2%
Inflammationinflammation	18	5.8%
Hemorrhage/blood loss/bleeding	13	4.2%
Swelling/ edema	10	3.2%
Hyperresponsive to stimuli	9	2.9%
Abscessa collection of pus	3	1%
Fistula	3	1%
Sinus perforation	2	0.6%
Hypersensitivity/allergic reaction	1	0.3%
Numbnessnumbness	1	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	TLC SP, ?3.75mm RT, SLActive? 8mm RXD	Product code DZE	All MAUDE reports
Reports	308	3,924,241	26,136,888
Share of that pool	—	0%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	100%	99.2%	36.2%
Classified as malfunction	0%	0.8%	62.3%
Filed by the manufacturer	93.5%	77.7%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code DZE

Brand	Reports	Latest 12 months	Classified as death
Biohorizons Dental Implant	58,732	0	0%
BioHorizons Inc.	57,020	25,536	0%
NobelActive Internal RP 4.3x10mm	49,098	9,528	0%
BLT ?4.1mm RC, SLA? 10mm, TiZr, Loxim	45,650	9,677	0%
NobelParallel CC RP 4.3x10mm	44,269	9,318	0%
BLT ?4.1mm RC, SLActive? 10mm, TiZr, NTP	41,672	7,531	0%
Unknown Implant	39,967	1,454	0%
NobelReplace CC RP 4.3x10mm	35,946	8,166	0%
NobelReplace CC PMC RP 4.3x10mm	34,447	8,690	0%
NobelActive Internal RP 4.3x11.5mm	33,117	5,704	0%
BLT ?3.3mm NC, SLA? 10mm, TiZr, Loxim	28,648	5,695	0%
BLT ?4.1mm RC, SLA? 10mm, Ti, Loxim	26,724	8,481	0%
BLT ?3.3mm NC, SLActive? 10mm, TiZr, NTP	26,540	4,680	0%
NobelActive Internal RP 4.3x13mm	25,556	3,764	0%
BLT ?4.1mm RC, SLA? 8mm, TiZr, Loxim	24,772	5,978	0%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about TLC SP, ?3.75mm RT, SLActive? 8mm RXD reports

How many FDA reports name TLC SP, ?3.75mm RT, SLActive? 8mm RXD?

308 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 193 in the latest 12 months.

What kinds of events are reported?

injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to osseointegrate (78.9%), loss of osseointegration (13.3%), difficult to insert (1.3%) and separation failure (0.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (93.5%) and distributor reports (6.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that TLC SP, ?3.75mm RT, SLActive? 8mm RXD was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.