FDA Adverse Event
Injury
Summary report: N
DENTAL ABUTMENT
MDR report key: 24952872
·
Received April 22, 2026
Report
- Report Number
- 0001038806-2026-02197
- Event Type
- Injury
- Date Received
- April 22, 2026
- Date of Event
- March 30, 2026
- Report Date
- April 22, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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,4.7,10,MTX,MG, CATALOG #: TSVTWB10, LOT #:1260688.
Description of Event or Problem · 0
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO ABUTMENT SCREW / CROWN FRACTURED. TOOTH NUMBER 30. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT. ADDITIONAL APPOINTMENT REQUIRED TO PLACE NEW IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271466 | DENTAL ABUTMENT | DZE | ZIMVIE US CORP LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |