BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 11737668 · Received April 28, 2021

    Report

    Report Number
    0002023141-2021-01072
    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
    00889024019928
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1232148). 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 NUMBER (1232148) FOR SIMILAR EVENTS 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.

    Additional Manufacturer Narrative · 0

    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 0002023141-2021-01072 AND 0002023141-2021-01072-1. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (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.

    Description of Event or Problem · 1

    DOCTOR INDICATED LACK OF PRIMARY STABILITY AT TOOTH SITE # 32. NO OTHER IMPLANTS PLACED. PATIENT WILL RETURN IN 30 DAYS FOR IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633226 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB10 1232148 00889024019928

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention