IMP,TSV,4.1MM,SBM,11.5
Report
- Report Number
- 0002023141-2021-03076
- Event Type
- Injury
- Date Received
- October 29, 2021
- Date of Event
- April 30, 2021
- Report Date
- March 18, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019232
- PMA / PMN Number
- K072589
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
THIS REPORT IS BEING RELAYED TO CORRECT AN OMISSION IN A PREVIOUS SUBMISSION (MFR-0002023141-2021-03076-1). (MFR-0002023141-2021-03076-1) SHOULD HAVE CONTAINED CORRECTED DATA FOR D4: EXPIRATION DATE AND H4: DEVICE MANUFACTURER DATE BUT ONLY CONTAINED H4: DEVICE MANUFACTURER DATE. THE OMITTED D4: EXPIRATION DATE WAS SUBSEQUENTLY SUBMITTED ON MFR-0002023141-2021-03076-2 D4 AS UPDATED INFORMATION WHICH SHOULD HAVE BEEN CORRECTED INFORMATION. THE CORRECT D4: EXPIRATION DATE IS NOV 1, 2022. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H10: ADDITIONAL NARRATIVE.
ZIMMERBIOMET COMPLAINT NUMBER (B)(4).
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELATED DEVIATIONS OR NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE ONE RELATED COMPLAINTS FOR THIS PRODUCT LOT. STERILIZATION RECORD WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. INFECTION: 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: EXPIRATION DATE. D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES'. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES' . H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER (B)(6).
IT WAS REPORTED THAT THE IMPLANT PRESENTED INFECTION AT THE IMPLANT SITE. THE IMPLANT WAS REMOVED AND THE ANTI-INFLAMMATORY TREATMENT WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1618839 | IMP,TSV,4.1MM,SBM,11.5 | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSV4B11 | 63850009 | 00889024019232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female | Required Intervention |