BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15970341 · Received December 13, 2022

    Report

    Report Number
    0002023141-2022-03083
    Event Type
    Injury
    Date Received
    December 13, 2022
    Report Date
    March 29, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED DATE OF EVENT UNKNOWN / NOT PROVIDED. LAST NAME UNKNOWN / NOT PROVIDED. PMA/510K: K011028, K013227.

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (B)(6) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE ACROSS THE THREADS. ADDITIONALLY, THERE WAS BONE/BLOOD TISSUE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED IN THE PER. THE REPORTED DEVICES WERE PLACED ON TOOTH # 18 (UNIVERSAL) FOR APPROXIMATELY 3 YEARS. X-RAY & PICTURE EVALUATION: X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1234034) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1234034) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. (B)(6) POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 FRACTURED HORIZONTALLY AND WAS REMOVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423766 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1234034 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention