FDA Adverse Event
Malfunction
Summary report: N
OSSEOTITE® IMPLANT 4 X 11.5MM
MDR report key: 25297509
·
Received May 27, 2026
Report
- Report Number
- 0001038806-2026-02914
- Event Type
- Malfunction
- Date Received
- May 27, 2026
- Date of Event
- May 5, 2026
- Report Date
- May 27, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- PMA / PMN Number
- K063286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). D4: UNIQUE IDENTIFIER (UDI) NUMBER NOT AVAILABLE.
Description of Event or Problem · 0
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 11 WITHOUT ANY DENTAL INJURY. DOCTOR ALSO INDICATED PATIENT DOES NOT WISH ANY STRESSFUL TREATMENT WITH IMPLANT'S REMOVAL. THEREFORE A BRIDGE WILL BE PLACED, REMOVAL WILL NOT BE NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114302 | OSSEOTITE® IMPLANT 4 X 11.5MM | DENTAL IMPLANT | DZE | ZIMVIE US CORP LLC | 75314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |