BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM

    MDR report key: 11942985 · Received June 4, 2021

    Report

    Report Number
    0002023141-2021-01465
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 6, 2021
    Report Date
    October 15, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020061
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TSV IMPLANT (TSVWB13) WITH FRACTURE MOUNT HEX WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED IMPLANT MOUNT HEX FRACTURED. SIGNS OF USE AND SOME DAMAGES TO THREADS, MOST LIKELY FROM REMOVAL PROCESS. PRE-EXISTING CONDITION AND TOOTH LOCATION AS NOTED ON THE PER ARE UNKNOWN. THE DEVICES WERE PLACED/REMOVED ON THE SAME DAY. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (FRACTURE). X-RAY OR PICTURE IMAGE WAS NOT PROVIDED BY CUSTOMER. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1241960. 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 (1241960) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP." H3: CHANGED "NO" TO "YES."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO A FRACTURE FIXTURE MOUNT. DURING THE IMPLANT PLACEMENT, A PIECE OF THE FIXTURE MOUNT FRACTURED. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT FROM STOCK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839157 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB13 1241960 00889024020061

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR