FDA Adverse Event
Malfunction
Summary report: N
ZFX¿ GENTEK¿, HEXED GOLD-TITE SCREW, CERTAIN
MDR report key: 25161456
·
Received May 13, 2026
Report
- Report Number
- 3008932779-2026-00018
- Event Type
- Malfunction
- Date Received
- May 13, 2026
- Date of Event
- March 17, 2026
- Report Date
- May 13, 2026
- Manufacturer
- ZFX GMBH
- Product Code
- NHA
- PMA / PMN Number
- K231915
- 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). A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED. E1: PHONE#: (B)(6). H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED.
Description of Event or Problem · 0
DOCTOR REPORTED SCREW FRACTURE AT TOOTH SITE 36 AFTER 2 MONTHS. IMPLANT CROWN WAS PLACED ON (B)(6) 2026 PATIENT CAME REFERRING LOOSENING, DOCTOR NOTICED SCREW WAS FRACTURED, THE REMOVAL OF THE FRACTURED BOTTOM PART HAS BEEN UNSUCCESSFUL SO FAR. DOCTOR ALSO INDICATED DAMAGED HEX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76012 | ZFX¿ GENTEK¿, HEXED GOLD-TITE SCREW, CERTAIN | DENTAL SCREW | NHA | ZFX GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male |