FDA Adverse Event
Malfunction
Summary report: N
CERTAIN GOLD-TITE HEXED SCREW
MDR report key: 25121872
·
Received May 8, 2026
Report
- Report Number
- 0001038806-2026-02546
- Event Type
- Malfunction
- Date Received
- May 8, 2026
- Date of Event
- December 9, 2024
- Report Date
- May 8, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- NHA
- PMA / PMN Number
- K072642
- 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 D4: UNIQUE IDENTIFIER (UDI) NUMBER: NOT AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED A SCREW FRACTURE AND THE SCREW WAS REMOVED. TOOTH LOCATION #11. THE SCREW WAS PLACED ON (B)(6) 2013 AND REMOVED ON (B)(6) 2024. BONE DENSITY TYPE: III.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280279 | CERTAIN GOLD-TITE HEXED SCREW | DENTAL SCREW | NHA | ZIMVIE US CORP LLC | 1152606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male |