Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Dental implant

3i T3 Non-Platform Switched Tapered Implant 3 25 X 11 5mm: medical device reports filed with FDA

180 reports name it, 2015–2026. Manufacturer given most often on reports: Biomet 3i. Product code DZE.

180
device reports naming the brand
0% of all MAUDE reports · about 16 a year
9
reports, 12 months to August 2026
26 in the 12 months before
1.7%
classified as malfunction
0.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 180 reports that name the brand "3i T3 Non-Platform Switched Tapered Implant 3 25 X 11 5mm" (dental implant), received between March 2015 and May 2026; the manufacturer given most often on reports is Biomet 3i. Spellings of one product vary from report to report.

9 reports arrived in the 12 months to August 2026, down 65% from 26 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 (98.3%) and malfunction (1.7%); 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 component missing (1.1%), mechanical problem (1.1%) and fracture (0.6%). The patient problems coded most often are osteolysis, inflammation and 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

048Sep 2021: 2Oct 2021: 2Nov 2021: 3Dec 2021: 02022Jan 2022: 0Feb 2022: 5Mar 2022: 3Apr 2022: 0May 2022: 2Jun 2022: 0Jul 2022: 1Aug 2022: 2Sep 2022: 2Oct 2022: 2Nov 2022: 4Dec 2022: 52023Jan 2023: 5Feb 2023: 8Mar 2023: 8Apr 2023: 3May 2023: 4Jun 2023: 0Jul 2023: 0Aug 2023: 3Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 82024Jan 2024: 1Feb 2024: 4Mar 2024: 3Apr 2024: 2May 2024: 2Jun 2024: 0Jul 2024: 1Aug 2024: 6Sep 2024: 5Oct 2024: 2Nov 2024: 1Dec 2024: 02025Jan 2025: 1Feb 2025: 0Mar 2025: 5Apr 2025: 2May 2025: 8Jun 2025: 2Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 1Nov 2025: 0Dec 2025: 12026Jan 2026: 1Feb 2026: 2Mar 2026: 2Apr 2026: 1May 2026: 1Jun 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

020392015: 320152019: 1520192020: 1820202021: 2520212022: 2620222023: 3920232024: 2720242025: 2020252026: 72026

Event type and report source

Event type, as classified on the report

Death0%0
Injury98.3%177
Malfunction1.7%3
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%180
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
Component missing21.1%0%
Mechanical problema mechanical problem21.1%0.1%
Fracturea broken bone10.6%1.6%
Unsealed device packaging10.6%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
Osteolysis8748.3%
Inflammationinflammation4122.8%
Painpain, site not specified3921.7%
Abscessa collection of pus179.4%
Swelling/ edema126.7%
Appropriate clinical signs, symptoms and conditions term/code not available21.1%
Discomfortdiscomfort21.1%
Erosion21.1%
Purulent discharge21.1%
Wound dehiscencea wound reopened21.1%
Bone fracture(s)10.6%
Headachehead pain10.6%
Inadequate osseointegration10.6%
Increased sensitivity10.6%
Paresthesia10.6%

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

In context

Measure3i T3 Non-Platform Switched Tapered Implant 3 25 X 11 5mmProduct code DZEAll MAUDE reports
Reports1803,924,24126,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports009
Classified as injury98.3%99.2%36.2%
Classified as malfunction1.7%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 3 25 X 11 5mm reports

How many FDA reports name 3i T3 Non-Platform Switched Tapered Implant 3 25 X 11 5mm?

180 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.

What kinds of events are reported?

injury (98.3%) and malfunction (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

component missing (1.1%), mechanical problem (1.1%), fracture (0.6%) and unsealed device packaging (0.6%). 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 3 25 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.