BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    MDR report key: 15535568 · Received October 4, 2022

    Report

    Report Number
    0002023141-2022-02486
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    September 16, 2021
    Report Date
    February 7, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019546
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW-VENT IMPLANT (TSVB8) WAS RETURNED FOR INVESTIGATION. VISUAL/PHYSICAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED EVENT (ALLERGIC REACTION). MEASUREMENTS WERE TAKEN WITH A CALIPER. FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN SPECIFICATION. PRE-EXISTING CONDITION NOTED ON THE PER IS POOR BONE DENSITY ¿ TYPE IV. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH 16 (FDI) FOR APPROXIMATELY 3 MONTHS. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1230639) 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 ZIMVIE. ALL STERILIZATION ACTIVITIES WERE CONDUCTED WITH NO NONCONFORMITIES PER STERILIZATION RECORDS. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT (1230639) FOR SIMILAR EVENTS AND NO OTHER COMPLAINTS ABOUT NONCONFORMING EVENTS WERE IDENTIFIED (KEYWORDS USED: ALLERGIC REACTION). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT CONDITIONS WERE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANT WAS INTEGRATED 2 MONTHS AFTER THE PLACEMENT, BUT PATIENT REPORTED TINGLING SENSATION, METALLIC TASTE AND PAIN SINCE THE IMPLANT PLACEMENT. POSSIBLE HYPERSENSITIVITY TO ONE OF THE COMPONENTS OF THE IMPLANT AND WAS REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2929334 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB8 1230639 00889024019546

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention