IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM
Report
- Report Number
- 0001038806-2026-00226
- Event Type
- Injury
- Date Received
- January 14, 2026
- Report Date
- March 2, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- UDI-DI
- 00889024019379
- PMA / PMN Number
- K061410
- Removal / Correction Number
- DATA ADDED
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDED 0001038806-2026-00224.
ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D2. TYPE OF DEVICE. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H4: DEVICE MANUFACTURER DATE. H10: ADDITIONAL NARRATIVE. THIS SUPPLEMENTAL REPORT IS SUBMITTED PER FDA EMAIL REQUEST IN ORDER TO SUBMIT PRODUCT CODE DZE
ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED . B3: DATE OF EVENT UNKNOWN / NOT PROVIDED . E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K011028, K013227.
WITH FDA
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 FRACTURED AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132035 | IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM | DENTAL IMPLANT | DZE | ZIMVIE US CORP LLC | 1240988 | 00889024019379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Unknown | Required Intervention |