BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    MDR report key: 11638223 · Received April 8, 2021

    Report

    Report Number
    0002023141-2021-00900
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    February 1, 2021
    Report Date
    August 26, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013124
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TWIST MP-1 3.75 MM 1 0 MM (1989), FIXTURE MOUNT AND PACKAGING WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF WEAR THREADS DUE TO USAGE. THE DEVICES WERE ENGAGED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT WAS PERFORMED. THE DEVICES WERE ABLE TO DISENGAGE UNDER APPLICATION OF EXCESSIVE FORCE. THEREFORE, THE REPORTED EVENT WAS CONFIRMED. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE REPORTED DEVICES WERE BEING PLACED IN AN UNKNOWN TOOTH SITE WHEN THE INCIDENT OCCURRED. X-RAY/PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (2019091341) 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 NUMBER (2019091341) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: DOES NOT DISENGAGE/RELEASE) AND 1 OTHER COMPLAINT WAS IDENTIFIED UNDER (B)(4). BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    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). AGE AND DATE OF BIRTH UNKNOWN/NOT PROVIDED. GENDER UNKNOWN/NOT PROVIDED. PATIENT WEIGHT UNKNOWN/NOT PROVIDED. PMA/510K: K943604. DEVICE MANUFACTURER DATE UNKNOWN/NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIXTURE MOUNT AND SCREW COULD NOT BE REMOVED FROM THE SPLINE TWIST. THE DOCTOR STOPPED USING THE IMPLANT AND PLACED ANOTHER PRODUCT IN THE CLINIC. TOOTH LOCATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535641 IMPL TWIST MP-1 3.75 MM 1 0 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1989 2019091341 00889024013124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention