FDA Adverse Event
Injury
Summary report: N
IMP,TSV,4.7,11.5,MTX,MG
MDR report key: 24839200
·
Received April 10, 2026
Report
- Report Number
- 0001038806-2026-01938
- Event Type
- Injury
- Date Received
- April 10, 2026
- Date of Event
- February 14, 2026
- Report Date
- May 27, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- UDI-DI
- 00889024020009
- PMA / PMN Number
- K101977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN/NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMVIE FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANT WAS FRACTURED AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260209 | IMP,TSV,4.7,11.5,MTX,MG | DENTAL IMPLANT | DZE | ZIMVIE US CORP LLC | 1268236 | 00889024020009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |