BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX,10MM

    MDR report key: 9711379 · Received February 14, 2020

    Report

    Report Number
    0002023141-2020-00299
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    December 27, 2019
    Report Date
    April 7, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE UPPER PART OF THE REPORTED DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR FROM USE, AND IS NOTED TO BE FRACTURED. THE RESTORATIVE ELEMENTS, INCLUDING THE SCREW, ARE UNDAMAGED. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 29 AND USED FOR APPROXIMATELY 1.5 YEARS. THE CUSTOMER HAS SENT AN X-RAY OF THE PRODUCT, AND IT CAN BE SEEN THAT THE OTHER FRACTURED PORTION OF THE IMPLANT IS CAUGHT IN THE IMPLANT SURGICAL SITE. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED DEVIATIONS OR 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 THAT THE DENTAL IMPLANT FRACTURED. THE REPORTED EVENT IS CONFIRMED FOLLOWING INSPECTION OF THE RETURNED PRODUCT. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES'. DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES' .

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K113753 / K112160. ADDRESS - LINE 1 UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DENTAL IMPLANT WAS FRACTURED. THE FRACTURE PORTION IS STILL IN THE PATIENT'S MOUTH AND WILL BE REMOVED AND REPLACE IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175536 IMP TM 4.1MM MTX,10MM DENTAL IMPLANT DZE ZIMMER DENTAL 63341708

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR