BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    MDR report key: 11782822 · Received May 6, 2021

    Report

    Report Number
    0002023141-2021-01145
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    March 25, 2021
    Report Date
    September 9, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019546
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4) ONE TSV IMPLANT WITH FRACTURE MOUNT HEX WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED IMPLANT MOUNT HEX FRACTURED AND REMAINED INSIDE THE IMPLANT DRIVE FEATURE. IMPLANT DAMAGE ALSO IDENTIFIED MOST LIKELY FROM THE REMOVAL PROCESS. PRE-EXISTING CONDITION AS NOTED ON THE PER IS UNKNOWN. THE DEVICE WAS LOCATED ON TOOTH SITE #46 (FDI) AND THE REPORTED ISSUE OCCURRED DURING PLACEMENT. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (FRACTURE). DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1241679. 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 (1241679) FOR SIMILAR EVENT (COMPLAINT KEYWORD CATEGORY: FRACTURE : MOUNT) AND NO OTHER COMPLAINT WAS IDENTIFIED. JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED DEVICES AND EVENTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PREMARKET IDENTIFICATION PMA/510(K) NUMBER K011028 AND K013227.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT DURING THE SURGERY THE DOCTOR WAS PLACING THE IMPLANT IN TOOTH LOCATION #46 AND WHEN HE TIGHTEN AND TORQUE WITH THE RATCHET THE HEX OF THE MOUNT FRACTURED INSIDE AND THE IMPLANT WAS REMOVED. ANOTHER IMPLANT WAS PLACED IN THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683677 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB8 1241679 00889024019546

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention