IMP,TSV,4.1,13,MTX,MG
Report
- Report Number
- 0002023141-2021-01073
- Event Type
- Injury
- Date Received
- April 28, 2021
- Date of Event
- March 1, 2021
- Report Date
- August 18, 2021
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019843
- PMA / PMN Number
- K101977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION AS THE PRODUCT WAS RECEIVED. ALL ADDITIONAL INFORMATION HAS BEEN REPORTED IN PREVIOUS SUBMISSIONS. SEE MDR REPORTS 0002023141-2021-01073 AND 0002023141-2021-01073-1. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: DEVICE AVAILABILITY AND PRODUCT RETURN DATE WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H10: NARRATIVE/DATA WAS UPDATED.
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: DEVICE AVAILABILITY AND RETURN DATE WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYOE OF INVESTIGATION CODES WERE ADDED: 4110, 4114 AND 3331. H10: NARRATIVE/DATA WAS UPDATED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1231309). 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1231309) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. MONTHLY TRENDING TO DATE HAS NOT IDENTIFIED ANY STATISTICAL TRIGGERS SUGGESTING POTENTIAL DESIGN OR MANUFACTURING RELATED ISSUES. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THE INABILITY TO PLACE IMPLANTS INTO OSTEOTOMY HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL MANUFACTURING NON-CONFORMANCES IMPACTING PRIMARY STABILITY. THEREFORE, ESCALATION TO CAPA IS NOT REQUIRED. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THIS REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE.
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
(B)(4). FAX NUMBER UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR LACK OF PRIMARY STABILITY EVENTS THAT DO NOT ALLEGE A DEFICIENCY WITH THE IMPLANT AND IDENTIFIED THAT THE REPORTED EVENT IS LIKELY DUE TO BIOLOGICAL FACTORS WHICH HAVE AN ADVERSE EFFECT ON IMPLANT STABILITY OR IS RELATED TO SURGICAL TECHNIQUE AND INSERTION TORQUE. DUE TO A WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED), IDENTIFYING A DEFINITIVE ROOT CAUSE IS GENERALLY NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. INVESTIGATION SUMMARY.
DOCTOR INDICATED LACK OF PRIMARY STABILITY. NO OTHER IMPLANTS PLACED. PATIENT WILL RETURN IN 30 DAYS FOR IMPLANT PLACEMENT. TOOTH LOCATION UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637483 | IMP,TSV,4.1,13,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVT4B13 | 1231309 | 00889024019843 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |