BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 10569828 · Received September 22, 2020

    Report

    Report Number
    0002023141-2020-01472
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    July 24, 2020
    Report Date
    November 23, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE IMPLANT IS UNDAMAGED. HOWEVER, AN ATTEMPT TO REMOVE THE MOUNT CONFIRMS THAT THE COMPONENTS ARE SEIZED TOGETHER AT THE MOUNT SCREW. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON AN UNKNOWN TOOTH SITE AND WAS REMOVED THE SAME DAY AS PLACEMENT. IT WAS NOTED DURING TESTING THAT THE MOUNT IS STUCK TO THE IMPLANT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: 1233624. 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 WAS 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: (1233624) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT: (TSVWB10). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED, AS THE COMPONENTS COULD NOT BE DISENGAGED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE POTENTIAL CAUSES FOR THE REPORTED EVENT ARE CUSTOMER ERROR IN SURGICAL PROTOCOL, AND EXTERNAL FORCES EXERTED ON THE IMPLANT ASSEMBLY. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM DEVICE INVESTIGATION CONFIRMED THAT IMPLANT FIXTURE MOUNT WAS UNABLE TO DISENGAGE FROM THE IMPLANT BODY; IMPLANT IS UNDAMAGED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSVWB10) WAS REMOVED. DENTIST SUSPECTS OF POSSIBLE IMPLANT FRACTURE AS THE IMPRESSION COPING WAS UNABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032378 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1233624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention