BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16097514 · Received January 4, 2023

    Report

    Report Number
    0002023141-2023-00034
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 8, 2022
    Report Date
    March 28, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510K: K011028, K013227.

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) WAS RETURNED FOR INVESTIGATION, ATTACHED IMAGES IN COMPLAINT. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED NO MALFUNCTIONS DETECTED THAT COULD LEAD TO REPORTED EVENT. ZIMVIE IS NOT RESPONSIBLE FOR ANY DAMAGE CAUSED BY THE CLINICIAN'S REMOVAL OF THE DEVICE. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENT. MEASUREMENTS OF THE IMPLANT WERE TAKEN USING A CALIPER (ID: CAL002C159; JUN 7, 2023). THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS WHEN IT LEFT ZIMVIE. PRE-EXISTING CONDITIONS NOTED ON THE PER WERE INADEQUATE ORAL HYGIENE, SYSTEMIC LUPUS ERYTHEMATOSUS, AND LOW BONE DENSITY (TYPE IV). THE REPORTED DEVICE WAS AT TOOTH LOCATION 13 (UNIVERSAL) AND WAS REPORTED AS BEING PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE X-RAYS OR IMAGES. APPROPRIATE DOCUMENTS WERE REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1252951). 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 EVENTS, 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 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY 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 NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED SINCE IT IS A MEDICAL CONDITION, AND NO X-RAY OR PICTORIAL EVIDENCE WAS AVAILABLE (PATIENT ANATOMICAL CONDITION AND DETAILS OF EVENT WERE UNKNOWN).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE FRACTURE. INITIAL IMPLANT OSTEOTOMY PREPARATION COMPLETED IN GRAFTED SITE AT TIME OF IMPLANT PLACEMENT. BUCCAL PLATE FRACTURED AND IMPLANT WAS LOCATED PARTLY OUTSIDE THE ALVEOLAR, NERVE, NECESSITATING IT REMOVED AND GRAFTING THE SITE. SYMPTOMS AS A RESULT OF THE EVENT: NONE.

    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
    1192862 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1252951 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention