BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 8 MM

    MDR report key: 8795279 · Received July 16, 2019

    Report

    Report Number
    0002023141-2019-00426
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    June 10, 2019
    Report Date
    October 29, 2019
    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 IMPL TWIST MP-1 3.75 MM 8 MM (1988) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AROUND THE IMPLANT THREADS AND MOUNT TINES. THE MOUNT SCREW DRIVE FEATURE IS DAMAGED. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THE MOUNT SCREW TOOK EXCESSIVE FORCES TO REMOVE, CONFIRMING THE COMPLAINT AND MALFUNCTION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WAS 1 ADDITIONAL RELATED COMPLAINT FOR THIS PRODUCT LOT. THIS ADDITIONAL COMPLAINT DESCRIBES A STUCK MOUNT, AND IS CONSIDERED A SIMILAR COMPLAINT. APPROPRIATE DOCUMENTATION WAS REVIEWED. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER EMAIL ADDRESS: NOT PROVIDED. PMA/510(K) NUMBER: K943604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (1988) BODY COULD NOT BE REMOVED FROM THE FIXTURE MOUNT. IMPLANT WAS REMOVED AND REPLACED WITH A NEW ONE. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587116 IMPL TWIST MP-1 3.75 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 2018070601

    Patients

    Seq Age Sex Outcome Treatment
    1