BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 12M M HEXAGON

    MDR report key: 11320676 · Received February 12, 2021

    Report

    Report Number
    0002023141-2021-00378
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    December 2, 2020
    Report Date
    May 13, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    0889024017474
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMPL TAPERED SP 3.7MM 12M M HEXAGON (SPMB12) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE VIAL IS MISSING THE IMPLANT MOUNT. THE CAP WAS NOTED TO ALREADY BE OPENED. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 64042414. 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 (64042414) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. AS THE PACKAGING WAS ALREADY OPENED, THE CIRCUMSTANCES OF DEVICE DELIVERY COULD NOT BE RECREATED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER CMP-(B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. IMPLANT DATE UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME OF OPENING THE IMPLANT, DOCTOR REALIZED THAT THERE WAS NO MOUNT. NO INJURY WAS CAUSED TO THE PATIENT AS A RESULT OF THIS EVENT, PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221412 IMPL TAPERED SP 3.7MM 12M M HEXAGON DENTAL IMPLANT DZE ZIMMER DENTAL 64042414 0889024017474

    Patients

    Seq Age Sex Outcome Treatment
    1