FDA Adverse Event
Malfunction
Summary report: N
DENTAL SCREW
MDR report key: 24941931
·
Received April 21, 2026
Report
- Report Number
- 0001038806-2026-02173
- Event Type
- Malfunction
- Date Received
- April 21, 2026
- Report Date
- April 21, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: CATALOG # UNKNOWN / NOT PROVIDED. D4: LOT/SERIAL # UNKNOWN / NOT PROVIDED. D4: DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. D4: DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. E1: EMAIL UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE ZIMMER ABUTMENT SCREW FRACTURED INSIDE OF A BIO HORIZON IMPLANT. CLINICIAN DID NOT KNOW THE ITEM OR LOT NUMBER OF THE ABUTMENT ONLY THAT THE LAB TOLD THEM THEY USED ZIMMER PRODUCTS IN A BIO HORIZON IMPLANT. NO REPLACEMENT SCREW REQUESTED .NO TOOLS PROVIDED AS IMPLANT IS NOT AN ZIMVIE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322511 | DENTAL SCREW | DZE | ZIMVIE US CORP LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |