FDA Adverse Event
Malfunction
Summary report: N
CERTAIN GOLD-TITE HEXED SCREW
MDR report key: 25328511
·
Received May 29, 2026
Report
- Report Number
- 0001038806-2026-02970
- Event Type
- Malfunction
- Date Received
- May 29, 2026
- Date of Event
- February 24, 2026
- Report Date
- May 29, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- NHA
- PMA / PMN Number
- K072642
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). D4: ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED, D10: CONCOMITANT MEDICAL PRODUCT: BOPT4313, T3® TAPERED IMPLANT 4/3 X 13MM, LOT: 2022060896. H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED.
Description of Event or Problem · 0
DOCTOR REPORTED LOOSENING OF PROSTHETIC PART AND LOOSE CONNECTION AT TOOTH SITE 44. DOCTOR ALSO INDICATED PERI-IMPLANTITIS WITH EDEMA AND INFLAMMATION. PATIENT REFERRED PAIN. PATIENT HAS BEEN RESCHEDULED FOR NEW PROSTHESIS AND SCREWS. SCREW PLACEMENT DATE: (B)(6) 2023 AND REMOVAL DATE: (B)(6) 2026. THIS REPORT REFERS TO SCREW LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102605 | CERTAIN GOLD-TITE HEXED SCREW | DENTAL SCREW | NHA | ZIMVIE US CORP LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |