FDA Adverse Event
Malfunction
Summary report: N
CERTAIN GOLD-TITE TM HEXED SCREW
MDR report key: 25183163
·
Received May 15, 2026
Report
- Report Number
- 0001038806-2026-02711
- Event Type
- Malfunction
- Date Received
- May 15, 2026
- Report Date
- May 12, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- NHA
- UDI-DI
- 00844868008538
- PMA / PMN Number
- K072642
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER: UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. A3: GENDER: UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT: UNKNOWN / NOT PROVIDED.
Description of Event or Problem · 0
DOCTOR REPORTED SCREW FRACTURE. PART OF THE SCREW WAS BLOWN AWAY, THE OTHER REMAINING PART WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252765 | CERTAIN GOLD-TITE TM HEXED SCREW | DENTAL SCREW | NHA | ZIMVIE US CORP LLC | 1283991 | 00844868008538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |