BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 9711347 · Received February 14, 2020

    Report

    Report Number
    0002023141-2020-00301
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    December 11, 2019
    Report Date
    April 21, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED DAMAGED INTERNAL HEX FEATURE AND ENGAGING THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER, THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICE WAS LOCATED ON TOOTH #(B)(6) AND WAS USED FOR 1 DAY DURING THE PLACEMENT PROCEDURE. THE CUSTOMER DID NOT PROVIDE PICTURES OR X-RAY IMAGES. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1232891). 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, WERE 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 (1232891) FOR SIMILAR EVENT AND NO OTHER COMPLAINTS WERE IDENTIFIED. FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DAMAGED DRIVE FEATURE) OR DEVICE (TSVWB10). 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER EMAIL ADDRESS, FAX NUMBER: NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT PLACEMENT, WHEN DOCTOR WAS TORQUEING THE IMPLANT DOWN, A POPPING / CRACKING SOUND CAME FROM THE IMPLANT (TSVWB10). DOCTOR COULD NOT CONFIRM IMPLANT FRACTURE; HOWEVER, IMPLANT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175158 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1232891

    Patients

    Seq Age Sex Outcome Treatment
    1