BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 8474203 · Received April 2, 2019

    Report

    Report Number
    0002023141-2019-00135
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    February 27, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 14 (UNIVERSAL) AND WAS NOT PLACED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1223074. 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 (1223074) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (STUCK MOUNT) OR PRODUCT (TSVB10). THEREFORE, BASED ON THE INVESTIGATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. 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

    ZIMMER BIOMET COMPLAINT (B)(4). PMA/510(K) NUMBER: K011028, K013227. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FIXTURE MOUNT COULD NOT BE REMOVED FROM THE IMPLANT (TSVB10). IMPLANT WAS NEVER IMPLANTED. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT. TOOTH LOCATION 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267406 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM IMPLANT DZE ZIMMER DENTAL 1223074

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR