BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12451973 · Received September 10, 2021

    Report

    Report Number
    0002023141-2021-02513
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    May 5, 2021
    Report Date
    January 27, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AN IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE WITH BONE/DEBRIS AND A FRACTURE AT THE COLLAR. THE REPORTED DEVICE LOCATION WAS 36 (FDI) AND WAS USED FOR APPROXIMATELY 7 YEARS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. 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 FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. 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 K01102 & K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT NECK WAS FRACTURED. THE DOCTOR CONFIRMS THAT THE PROCEDURE COULD NOT BE COMPLETED THE SAME DAY WITH ANOTHER IMPLANT AND ALSO CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY IMPACT ON HIS HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349604 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANY DZE ZIMMER DENTAL 61977590

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention