BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13963044 · Received March 31, 2022

    Report

    Report Number
    0002023141-2022-00759
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    January 12, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER: (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY THE MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) AND MOUNT SCREW WERE RETURNED FOR INVESTIGATION (SEE IMAGES ATTACHED IN COMPLAINT). VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SCREW FRAGMENT IN THE IMPLANT DRIVE FEATURE. ADDITIONALLY, THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS/VENT DUE TO USAGE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES AND EVENT. PRE-EXISTING CONDITION NOTED ON THE PER WAS 'LOW BONE DENSITY ¿TYPE IV'. THE DEVICES HAD BEEN PLACED ON TOOTH #21 (FDI) FOR APPROXIMATELY 2 YEARS. X-RAY & PICTURE EVALUATION: X-RAY/PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS & PRECAUTIONS. PER THE APPLICABLE IFU, PATIENT FACTORS SUCH AS SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE COMPONENT FRACTURE. DHR REVIEW: DHR REVIEW FOR THE LOT: (1233700) 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1233700) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: SCREW FRACTURE) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCTS. 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 ABUTMENT SCREW (MOUNT) FRACTURED INSIDE THE IMPLANT IT WAS NOT POSSIBLE TO REMOVE THE SCREW THEREFORE THE IMPLANT 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
    2188920 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1233700 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention