BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 16397473 · Received February 17, 2023

    Report

    Report Number
    0002023141-2023-00576
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    November 16, 2022
    Report Date
    May 25, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019522
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). /K011028/K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES.' H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES.' ONE IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED ONE FRACTURED MOUNT HEX. ADDITIONALLY, ONE IMPLANT AND ONE MOUNT WERE ALSO RETURNED UNDAMAGED. THE IMPLANT HAS SIGNS OF USE, APPARENT BONE / TISSUE WAS SEEN ATTACHED TO THE EXTERNAL THREADS. NO DAMAGE IDENTIFIED WITH THE ADDITIONAL MOUNT RETURNED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS UNKNOWN BONE DENSITY TYPE. THE REPORTED DEVICE WAS LOCATED ON AN UNKNOWN TOOTH SITE (FDI) AND WAS USED, PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS 4869 REV 9-10/19. INFORMATION IDENTIFIED: 'CONTRAINDICATIONS' 'WARNINGS' 'CHANGES IN PERFORMANCE' 'ADVERSE EFFECTS' DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1251812). 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, WERE 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 (1251812) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: 'FRACTURE MOUNT.' POST MARKET TRENDING REVIEW: MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FRACTURE MOUNT) OR PRODUCT (TSVB13). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING VISUAL EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOUNT FRACTURED. WHILE TRYING TO REMOVE THE MOUNT, THE IMPLANT GOT DAMAGED AND HAD TO BE REMOVED. MOUNT FRACTURED AT THE BODY (HEXAGON), PROCEDURE COMPLETED PLACING A TSVB13 IMPLANT.

    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
    116240 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB13 1251812 00889024019522

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male