BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 13507128 · Received February 10, 2022

    Report

    Report Number
    0002023141-2022-00304
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    January 5, 2022
    Report Date
    July 22, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBER IS K013227.

    Additional Manufacturer Narrative · 0

    AN IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 11.5MM (TSVB11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS AND BONE. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT WITH AN IN-HOUSE STOCK ABUTMENT AND DOES NOT ENGAGE INTO THE THREADS. DAMAGE THREADS TO THE TSVB11. MALFUNCTION. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF THE DEVICE USAGE IS UNKNOWN. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9 ¿ 10/19 INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1250182). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1250182) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DAMAGED THREADS AND DOES NOT SEAT POST MARKET TREND REVIEW: MAY 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 FOR THE DAMAGED THREADS ON THE TSVB11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTERNAL TREADING OF THE IMPLANT WERE DAMAGED. IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156836 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1250182 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose