BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 15657374 · Received October 24, 2022

    Report

    Report Number
    0002023141-2022-02671
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    October 4, 2022
    Report Date
    March 2, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). PATIENT WEIGHT NOT PROVIDED. ADDITIONAL 510(K) NUMBER IS K013227.

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) AND ONE (1) UNKNOWN ZIMMER SCREW WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED A FRACTURE AT THE IMPLANTS COLLAR. A SCREW WAS IDENTIFIED INSIDE THE IMPLANT. ZIMVIE IS NOT RESPONSIBLE FOR ANY DAMAGE CAUSED BY THE CLINICIAN'S REMOVAL OF THE DEVICE. 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 NOT REPORTED. BONE DENSITY WAS MODERATE DENSITY (TYPE II). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 46 (FDI) AND WAS USED FOR APPROXIMATELY 10 MONTHS. X-RAY & PICTURE EVALUATION: THE CUSTOMER DID NOT PROVIDE ANY IMAGES FOR THE REPORTED EVENT. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1244050. 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 WAS PERFORMED FOR THE REPORTED LOT NUMBER 1244050 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW: (UNKNOWN SCREW): DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT ITEM/LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED AS PHYSICAL EVALUATION IDENTIFIED THE FRACTURED IMPLANT AND SCREW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AT THE SITE.

    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
    2804601 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1244050 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention