BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    MDR report key: 10602886 · Received September 29, 2020

    Report

    Report Number
    0002023141-2020-01523
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    August 15, 2020
    Report Date
    January 5, 2021
    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

    ONE ZIMMER SPLINE IMPLANT (1989) AND FIXTURE MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF WEAR AND BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. HOWEVER, THE DEVICES HAD NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT WAS PERFORMED. THE DEVICES WERE ABLE TO ENGAGE AND DISENGAGE EACH OTHER SUCCESSFULLY. THEREFORE, THE REPORTED EVENT WAS UNCONFIRMED. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE REPORTED DEVICES WERE BEING PLACED ON TOOTH #19 (UNIVERSAL) WHEN THE INCIDENT OCCURRED. X-RAY/PICTURE IMAGE WAS NOT PROVIDED. DHR REVIEW FOR THE LOT (2019060339) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (2019060339) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G7: CHECKED "FOLLOW-UP."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). PATIENT AGE. ADDITIONAL PMA/510(K) NUMBER: K943604. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (1989) WAS REMOVED DUE TO IMPLANT FIXTURE MOUNT WAS UNABLE TO BE DISENGAGE FROM THE IMPLANT BODY. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066678 IMPL TWIST MP-1 3.75 MM 1 0 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2019060339

    Patients

    Seq Age Sex Outcome Treatment
    1