FDA Adverse Event
Malfunction
Summary report: N
TSX IMPLANT, 3.7MMD, 13MML
MDR report key: 25059829
·
Received May 1, 2026
Report
- Report Number
- 0001038806-2026-02425
- Event Type
- Malfunction
- Date Received
- May 1, 2026
- Date of Event
- April 15, 2026
- Report Date
- May 1, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- UDI-DI
- 00844868045069
- PMA / PMN Number
- K220978
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED.
Description of Event or Problem · 0
PATIENT REPORTED TO CLINIC FOR REPLACEMENT OF IMPLANTS #29 AND #30. WHILE TRYING TO LOAD IMPLANT FOR SITE #29, UNABLE TO SEAT ANY OF THE IMPLANT DRIVERS INTO PLATFORM. DOCTOR REPORTED POSSIBLE WARPING TO IMPLANT PLATFORM. A LARGER IMPLANT WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290573 | TSX IMPLANT, 3.7MMD, 13MML | DENTAL IMPLANT | DZE | ZIMVIE US CORP LLC | 1275868 | 00844868045069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |