Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Dental implant

3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mm: medical device reports filed with FDA

266 reports name it, 2019–2025. Manufacturer given most often on reports: Biomet 3i. Product code DZE.

266
device reports naming the brand
0% of all MAUDE reports · about 38 a year
4
reports, 12 months to August 2026
45 in the 12 months before
3%
classified as malfunction
0.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

266 medical device reports received by FDA name the brand "3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mm" (dental implant); the manufacturer given most often on reports is Biomet 3i; received from June 2019 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

4 reports arrived in the 12 months to August 2026, down 91% from 45 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 (97%) and malfunction (3%); 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 fracture (3.4%), mechanical problem (2.6%) and patient-device incompatibility (1.1%). The patient problems coded most often are osteolysis, 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

048Sep 2021: 7Oct 2021: 2Nov 2021: 4Dec 2021: 42022Jan 2022: 0Feb 2022: 0Mar 2022: 3Apr 2022: 2May 2022: 8Jun 2022: 6Jul 2022: 6Aug 2022: 5Sep 2022: 2Oct 2022: 3Nov 2022: 3Dec 2022: 12023Jan 2023: 2Feb 2023: 2Mar 2023: 7Apr 2023: 4May 2023: 5Jun 2023: 1Jul 2023: 4Aug 2023: 5Sep 2023: 2Oct 2023: 2Nov 2023: 8Dec 2023: 22024Jan 2024: 4Feb 2024: 1Mar 2024: 3Apr 2024: 2May 2024: 8Jun 2024: 4Jul 2024: 2Aug 2024: 7Sep 2024: 1Oct 2024: 8Nov 2024: 2Dec 2024: 42025Jan 2025: 0Feb 2025: 2Mar 2025: 8Apr 2025: 4May 2025: 2Jun 2025: 8Jul 2025: 3Aug 2025: 3Sep 2025: 0Oct 2025: 1Nov 2025: 3Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

024472019: 1920192020: 3720202021: 4720212022: 3920222023: 4420232024: 4620242025: 342025

Event type and report source

Event type, as classified on the report

Death0%0
Injury97%258
Malfunction3%8
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%266
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
Fracturea broken bone93.4%1.6%
Mechanical problema mechanical problem72.6%0.1%
Patient-device incompatibilitythe device did not suit the patient31.1%0%
Component missing20.8%0%
Detachment of device or device componentpart of the device came off20.8%0%
Failure to osseointegrate10.4%62.8%
Problem with removal of enzymatic cleaner10.4%0%
Separation failure10.4%0.1%
Separation problem10.4%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
Osteolysis12747.7%
Painpain, site not specified6022.6%
Inflammationinflammation5420.3%
Abscessa collection of pus207.5%
Swelling/ edema155.6%
Erosion62.3%
Hypersensitivity/allergic reaction51.9%
Sinus perforation41.5%
Appropriate clinical signs, symptoms and conditions term/code not available20.8%
Bone fracture(s)20.8%
Discomfortdiscomfort10.4%
Fistula10.4%
Inadequate osseointegration10.4%
Nerve damage10.4%
Paresthesia10.4%

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

In context

Measure3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mmProduct code DZEAll MAUDE reports
Reports2663,924,24126,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports009
Classified as injury97%99.2%36.2%
Classified as malfunction3%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 3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mm reports

How many FDA reports name 3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mm?

266 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.

What kinds of events are reported?

injury (97%) and malfunction (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (3.4%), mechanical problem (2.6%), patient-device incompatibility (1.1%), component missing (0.8%) and detachment of device or device component (0.8%). 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 3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mm 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.