BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,10,MTX,MG

    MDR report key: 12409131 · Received September 1, 2021

    Report

    Report Number
    0002023141-2021-02405
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 2, 2021
    Report Date
    January 21, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019829
    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. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: TYPE OF INVESTIGATION CODE WAS ADDED: 3331 AND 4114. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243475). 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 EVENTS WERE 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 (1243475) AND THERE ARE NO OTHER COMPLAINTS FOR THE REPORTED PRODUCT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORD: UNABLE TO PLACE IN OSTEOTOMY). OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (UNABLE TO PLACE IN OSTEOTOMY) OR PRODUCT (TSVT4B10). AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THESE REPORTED EVENTS 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 ADDITIONAL INFORMATION AND DEVICE EVALUATION. 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.

    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). 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 FACTORS (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 LOCATION #25. NEW IMPLANT WILL BE PLACED ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301620 IMP,TSV,4.1,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B10 1243475 00889024019829

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention