BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 10276990 · Received July 15, 2020

    Report

    Report Number
    0002023141-2020-01053
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 16, 2020
    Report Date
    September 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: METHOD CODE WAS ADDED: 3331 AND 4109. H6: RESULTS CODE WAS ADDED: 180. H6: CONCLUSIONS CODE WAS ADDED: 4307. THE REPORTED DEVICE AND ITS PACKAGING WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF HEALING CAP STUCK WAS CONFIRMED. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR AND SCRATCHES ABOUT THE IMPLANT TINES. THE MOUNT IS MINIMALLY WORN. THE IMPLANT VIAL IS NOTED TO BE PARTLY MELTED AND WARPED ALONG ITS LENGTH. THE HEALING CAP COULD NOT BE REMOVED FROM THE VIAL DUE TO THE VIAL WARPING. THE REPORTED EVENT COULD BE RECREATED, AS THE HEALING CAP IS CONFIRMED TO BE STUCK IN THE VIAL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBER IS K962106.

    Description of Event or Problem · 1

    DR. INDICATED MALFUNCTION. THE HEALING CAP STUCK IN IMPLANT 1993. ANOTHER IMPLANT HELD AT THE DENTAL OFFICE WAS PLACED. TOOTH LOCATION # 31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741289 IMPL TWIST MP-1 5.0 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2019090493

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR