BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13725289 · Received March 10, 2022

    Report

    Report Number
    0002023141-2022-00626
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    February 1, 2022
    Report Date
    August 16, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    (1) IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED BONE / TISSUE ATTACHED TO THE IMPLANT EXTERNAL THREADS. FRACTURE AT COLLAR AND SCREW FRACTURE FOUND INSIDE. NO PRE-EXISTING CONDITIONS NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH #30 AND WAS USED FOR APPROXIMATELY 4 YEARS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS (4894 REV 6 - 08/19) 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 (63965395). 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 (63965395) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE : IMPLANT AND MEDICAL : BONE LOSS POST MARKET TREND REVIEW: JUNE 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 COULD NOT BE VERIFIED FOR BONE LOSS HOWEVER MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOR FRACTURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AND DEVELOPING BONE LOSS. PATIENT WILL RETURN FOR ADDITIONAL APPOINTMENTS.

    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
    1525717 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 63965395 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention