BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    MDR report key: 8537337 · Received April 22, 2019

    Report

    Report Number
    0002023141-2019-00175
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    March 18, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SP 3.7MM 12M M OCTAGON (SPB12) WAS RETURNED FOR INVESTIGATION ATTACHED TO A MATING MOUNT. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS AND MOUNT SCREW. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THAT THE SCREW COULD BE EASILY REMOVED, HOWEVER THE MOUNT HEX TOOK EXCESSIVE FORCE TO REMOVE. DEBRIS WAS FOUND IN THE INTERFACE BETWEEN THE MOUNT AND IMPLANT WHEN REMOVED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2019012075. 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 (2019012075) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT(STUCK MOUNT) OR DEVICE (SPB12). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER EMAIL ADDRESS, FAX NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: K011245, K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PLACEMENT THE MOUNT COULD NOT DISENGAGE FROM IMPLANT (B)(4). ANOTHER IMPLANT WAS USED TO FINISH THE PROCEDURE. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329064 IMPL TAPERED SP 3.7MM 12M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 2019012075

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR