IMP,TSV,4.7,8,MTX,MG
Report
- Report Number
- 0002023141-2022-00074
- Event Type
- Injury
- Date Received
- January 14, 2022
- Date of Event
- November 12, 2021
- Report Date
- June 21, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020030
- PMA / PMN Number
- K101977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2021-00075. ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K101880 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.
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-00075-2. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. H6: TYPE OF INVESTIGATION CODE WAS ADDED: 3331 AND 4110. TSVTWB8 - DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1242677). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. UNK. IMPLANT - DHR REVIEW COULD NOT BE CONDUCTED SINCE THE SUBJECT LOT NUMBER WAS UNKNOWN. TSVTWB8 - STERILIZATION RECORD (OP160) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. TSVTWB8 - COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1242677) FOR SIMILAR EVENTS AND THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENTS. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (INFECTION) OR FOR THE REPORTED DEVICE (TSVTWB8). AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENT REMAINS NON-VERIFIABLE AS IT IS A MEDICAL CONDITION.
THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA/INFORMATION. THE ASSOCIATED MDR REPORT NUMBER WAS ENTERED INCORRECTLY AS 0002023141-2021-00075. CORRECTION: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE THE ASSOCIATED REPORT: 0002023141-2022-00075.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN ON THE LOWER RIGHT SIDE AND INFECTION WAS REVEALED AROUND THE IMPLANTS AT TOOTH LOCATIONS #29 AND 30. THE IMPLANTS WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611039 | IMP,TSV,4.7,8,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVTWB8 | 1242677 | 00889024020030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |