FDA Adverse Event
Malfunction
Summary report: N
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
MDR report key: 24676531
·
Received March 24, 2026
Report
- Report Number
- 0001038806-2026-01580
- Event Type
- Malfunction
- Date Received
- March 24, 2026
- Date of Event
- March 2, 2026
- Report Date
- May 19, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- UDI-DI
- 00889024020085
- PMA / PMN Number
- K061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER K011028, K013227.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DOCTOR FOLLOWED THE TSV SURGICAL PROCEDURES TO PLACE THE IMPLANT. HOWEVER, WHEN DOCTOR USED RSR ATTACHED TO THE FIXTURE MOUNT TO THREAD TSVWB8 INTO THE PREPARED SITE, THE HEX CONNECTION OF THE FIXTURE MOUNT BROKEN DURING THE TIME. MOREOVER, THE BROKEN HEXAGONAL CONNECTOR OF THE FMT BECAME STUCK AT THE IMPLANT CONNECTION AND COULD NOT BE REMOVED. SO, THE DOCTOR REMOVED THE ORIGINAL IMPLANT AND REPLACED IT WITH A NEW ONE. TOOTH SITE # 47.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27057 | IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM | DENTAL IMPLANT | DZE | ZIMVIE US CORP LLC | 1273562 | 00889024020085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |