BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL,13M

    MDR report key: 9131369 · Received September 27, 2019

    Report

    Report Number
    0002023141-2019-00810
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    August 19, 2019
    Report Date
    November 22, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP TM 4.1MM MTX FULL,13M (ITEM # TMT4B13) ASSEMBLY WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURING OF THE IMPLANT AT ITS LOWER PORTION AS REPORTED. 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 WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. THE ALLEGED DEVICE MALFUNCTION WAS CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT, DEVICE EXPIRATION, UDI (B)(4), DATE RECEIVED BY MANUFACTURER, CHECKED "FOLLOW-UP", CHECKED FOLLOW-UP TYPE, CHANGED "NO" TO "YES", DATE OF MANUFACTURE, ENTERED EVALUATION CODES, ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K NUMBERS: K113753 AND K112160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT PLACEMENT THE IMPLANT FRACTURED AND HAD TO BE REMOVED. IT WAS NOTED THAT THE PATIENT HAD SOME BONE LOSS. THE SITE WAS GRAFTED AND ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924899 IMP TM 4.1MM MTX FULL,13M DENTAL IMPLANT DZE ZIMMER DENTAL 1218565

    Patients

    Seq Age Sex Outcome Treatment
    1