BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 9176287 · Received October 10, 2019

    Report

    Report Number
    0002023141-2019-00870
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    August 30, 2019
    Report Date
    December 6, 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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMPL TWIST MP-1 5.0 MM 8 MM (1993) WAS RETURNED FOR INVESTIGATION WITH A MOUNT ENGAGED TO THE IMPLANT. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED MINOR WEAR ABOUT THE IMPLANT THREADS AND THE ENGAGEMENT FEATURES. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THE MOUNT COULD BE EASILY REMOVED WITH TSVKIT HAND TOOLS. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 31 AND WAS REMOVED THE SAME DAY AS PLACEMENT. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. COMPLAINANT REPORTED PATIENT THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT, ANOTHER IMPLANT WAS PLACED. THE REPORTED COMPLAINT IS UNCONFIRMED BASED ON FUNCTIONAL TESTING OF THE RETURNED PRODUCT. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT, EXPIRATION DATE, UDI, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, FOLLOW-UP NUMBER, FOLLOW UP TYPE, DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES', DEVICE MANUFACTURE DATE, EVALUATION CODES, ADDITIONAL NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER - K962106.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BODY COULD NOT BE REMOVED FROM THE FIXTURE MOUNT. AN OTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970404 IMPL TWIST MP-1 5.0 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 63758302

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR