FDA Adverse Event
Malfunction
Summary report: N
DENTAL SCREW
MDR report key: 25204382
·
Received May 18, 2026
Report
- Report Number
- 0001038806-2026-02741
- Event Type
- Malfunction
- Date Received
- May 18, 2026
- Date of Event
- April 27, 2026
- Report Date
- May 15, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER: (B)(4). A4: PATIENT WEIGHT 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. G4: PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED. H11: D10 - MEDICAL PRODUCT - IMP, TSV, 4.7,11.5, MTX, MG CATALOG#: TSVTWB11, LOT#:1221531.
Description of Event or Problem · 0
IT WAS REPORTED THAT IMPLANT WAS RETURNED WITH A FRACTURED ZIMMER SCREW INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247512 | DENTAL SCREW | DZE | ZIMVIE US CORP LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |