FDA Adverse Event
Malfunction
Summary report: N
CERTAIN® TITANIUM LARGE HEXED SCREW
MDR report key: 25134622
·
Received May 11, 2026
Report
- Report Number
- 0001038806-2026-02582
- Event Type
- Malfunction
- Date Received
- May 11, 2026
- Date of Event
- April 5, 2026
- Report Date
- May 11, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- UDI-DI
- 00844868006138
- PMA / PMN Number
- K972444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4) A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS . ILRGHT, CERTAIN® TITANIUM LARGE HEXED SCREW LOT 1273390. G4: PREMARKET IDENTIFICATION K072642.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SCREWS FRACTURED. SCREWS PLACED ON (B)(6) 2025 AND REMOVED ON (B)(6) 2026. PATIENT HAD TO RETURN AND THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301589 | CERTAIN® TITANIUM LARGE HEXED SCREW | DENTAL SCREW | DZE | ZIMVIE US CORP LLC | 1273390 | 00844868006138 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |