FDA Adverse Event
Malfunction
Summary report: N
DENTAL SCREW
MDR report key: 25276857
·
Received May 26, 2026
Report
- Report Number
- 0001038806-2026-02866
- Event Type
- Malfunction
- Date Received
- May 26, 2026
- Report Date
- May 27, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- NHA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). D10: ILPC341U, CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H). G4: PMA/510(K) NUMBER NOT AVAILABLE. PRODUCT HAS BEEN RECEIVED BY ZIMVIE AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 0
DURING PRODUCT EVALUATION, A FRACTURED SCREW FRAGMENT WAS SEEN STUCK INSIDE OF THE ABUTMENT'S TOP END.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31195 | DENTAL SCREW | NHA | ZIMVIE US CORP LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DENTAL ABUTMENT-SEE H10 NARRATIVE |