FDA Adverse Event
Malfunction
Summary report: N
TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 6.5MM(P) 5MM(H)
MDR report key: 25128125
·
Received May 8, 2026
Report
- Report Number
- 0001038806-2026-02572
- Event Type
- Malfunction
- Date Received
- May 8, 2026
- Date of Event
- April 3, 2026
- Report Date
- May 12, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- NHA
- UDI-DI
- 00844868045885
- PMA / PMN Number
- K212730
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: CATALOG AND LOT NUMBER UNKNOWN / NOT PROVIDED. 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
IT WAS REPORTED THAT TWO (2) YEARS AFTER THE RESTORATION WAS PLACED, THE SCREW RETAINED CROWN LOOSENED ENABLING FOOD / BACTERIA TO BECOME TRAPPED THAT LED TO BONE LOSS AND IMPLANT FAILURE AT TOOTH SITE #14.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280344 | TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 6.5MM(P) 5MM(H) | DENTAL SCREW | NHA | ZIMVIE US CORP LLC | 1273154 | 00844868045885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | TSX54B10, TSX IMPLANT, 5.4MMD, 10MML. |