BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 8496700 · Received April 9, 2019

    Report

    Report Number
    0002023141-2019-00148
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 11, 2019
    Report Date
    July 10, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM (TSVB13) 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 VENT. 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. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 63725066. 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 (63725066) 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 (TSVB13). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED; HOWEVER, THE PROBABLE CAUSE MAY BE ASSOCIATED TO EXCESSIVE LOADING ON MOUNT/IMPLANT ASSEMBLY. 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

    ZIMMER BIOMET COMPLAINT 2031527-2019-00177 PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOUNT COULD NOT DISENGAGE FROM IMPLANT (TSVB13). IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289293 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 63725066

    Patients

    Seq Age Sex Outcome Treatment
    1