Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Dental implant

Touareg -S Dental Implant 4 2d 13l: medical device reports filed with FDA

222 reports name it, 2024–2026. Manufacturer given most often on reports: Adin Dental Implant Systems. Product code DZE.

222
device reports naming the brand
0% of all MAUDE reports · about 99 a year
118
reports, 12 months to August 2026
72 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

222 medical device reports received by FDA name the brand "Touareg -S Dental Implant 4 2d 13l" (dental implant); the manufacturer given most often on reports is Adin Dental Implant Systems; received from April 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

118 reports arrived in the 12 months to August 2026, up 64% from 72 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 osseointegration problem (92.8%), patient device interaction problem (18.5%) and loss of osseointegration (11.3%). The patient problems coded most often are failure of implant, inadequate osseointegration and implant pain. 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

02243Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 1May 2024: 0Jun 2024: 13Jul 2024: 17Aug 2024: 1Sep 2024: 3Oct 2024: 9Nov 2024: 7Dec 2024: 32025Jan 2025: 9Feb 2025: 0Mar 2025: 3Apr 2025: 0May 2025: 0Jun 2025: 10Jul 2025: 9Aug 2025: 19Sep 2025: 2Oct 2025: 6Nov 2025: 6Dec 2025: 62026Jan 2026: 43Feb 2026: 40Mar 2026: 0Apr 2026: 3May 2026: 2Jun 2026: 1Jul 2026: 7Aug 2026: 2

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

049982024: 5420242025: 7020252026: 982026

Event type and report source

Event type, as classified on the report

Death0%0
Injury100%222
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%222
Voluntary report0%0
User facility report0%0
Distributor report0%0
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)ReportsShareShare across product code
Osseointegration problem20692.8%7.7%
Patient device interaction problem4118.5%0.3%
Loss of osseointegration2511.3%22.4%
Failure to osseointegrate188.1%62.8%
Migration or expulsion of device20.9%0%
Device appears to trigger rejection10.5%0%

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)ReportsShare
Failure of implant222100%
Inadequate osseointegration11551.8%
Implant pain3214.4%
Osteolysis2310.4%
Granuloma41.8%
Scar tissue31.4%
Sinus perforation20.9%

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

In context

MeasureTouareg -S Dental Implant 4 2d 13lProduct code DZEAll MAUDE reports
Reports2223,924,24126,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports009
Classified as injury100%99.2%36.2%
Classified as malfunction0%0.8%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Biohorizons Dental Implant58,73200%
BioHorizons Inc.57,02025,5360%
NobelActive Internal RP 4.3x10mm49,0989,5280%
BLT ?4.1mm RC, SLA? 10mm, TiZr, Loxim45,6509,6770%
NobelParallel CC RP 4.3x10mm44,2699,3180%
BLT ?4.1mm RC, SLActive? 10mm, TiZr, NTP41,6727,5310%
Unknown Implant39,9671,4540%
NobelReplace CC RP 4.3x10mm35,9468,1660%
NobelReplace CC PMC RP 4.3x10mm34,4478,6900%
NobelActive Internal RP 4.3x11.5mm33,1175,7040%
BLT ?3.3mm NC, SLA? 10mm, TiZr, Loxim28,6485,6950%
BLT ?4.1mm RC, SLA? 10mm, Ti, Loxim26,7248,4810%
BLT ?3.3mm NC, SLActive? 10mm, TiZr, NTP26,5404,6800%
NobelActive Internal RP 4.3x13mm25,5563,7640%
BLT ?4.1mm RC, SLA? 8mm, TiZr, Loxim24,7725,9780%

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 Touareg -S Dental Implant 4 2d 13l reports

How many FDA reports name Touareg -S Dental Implant 4 2d 13l?

222 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 118 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?

osseointegration problem (92.8%), patient device interaction problem (18.5%), loss of osseointegration (11.3%), failure to osseointegrate (8.1%) and migration or expulsion of device (0.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Touareg -S Dental Implant 4 2d 13l 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.