IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
Report
- Report Number
- 0002023141-2022-00455
- Event Type
- Injury
- Date Received
- February 23, 2022
- Date of Event
- December 9, 2021
- Report Date
- April 22, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019515
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K013227. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K013227. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). DURING ONGOING INVESTIGATON, IT WAS IDENTIFIED THAT THE ITEM RETURNED IS A TSVB10 INSTEAD OF A TSVB11 PREVIOUSLY REPORTED ON MFR0002023141-2022-00455. THIS REPORT IS INTENDED TO UPATE THE REFERENCE ON D4 SECTION TO TSVB10 AND LOT NUMBER TO UNKNOWN. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G4: PMA/510(K) NUMBER : K011028 AND K013227 .
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #UNK WAS REMOVED DUE TO INFECTION.
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #UNK WAS REMOVED DUE TO INFECTION.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1147222 | IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVB11 | 1237433 | 00889024019515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |