BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 12M M HEXAGON

    MDR report key: 11601088 · Received April 1, 2021

    Report

    Report Number
    0002023141-2021-00807
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    February 22, 2021
    Report Date
    July 15, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017474
    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). TWO (2) IMPL TAPERED SP 3.7MM 12M M HEXAGON (SPMB12) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED BOTH IMPLANTS FRACTURED AROUND THE COLLAR REGION. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2019110202). 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 (2019110202) FOR SIMILAR EVENT KEYWORD CATEGORY (FUNCTIONAL: FRACTURE : IMPLANT) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    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 (B)(4). PMA/510(K) NUMBER: K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTS FRACTURED AT THE MOMENT OF IMPLANT PLACEMENT. DOCTOR PLACED OTHER IMPLANT IN THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499584 IMPL TAPERED SP 3.7MM 12M M HEXAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPMB12 2019110202 00889024017474

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR