BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL,13M

    MDR report key: 7915321 · Received September 27, 2018

    Report

    Report Number
    0002023141-2018-00816
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    June 23, 2018
    Report Date
    January 24, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ZIMMER TRABECULAR METAL IMPLANT WAS RETURNED FOR INSPECTION WITH AN ATTACHED CROWN. A VISUAL INSPECTION REVEALED THAT THE DEVICE SHOWS SIGNS OF WEAR ABOUT THE REMAINING THREADED REGION. THE DEVICE IS CONFIRMED TO BE FRACTURED AT THE TM INTERFACE. THE OTHER HALF OF THE DEVICE WAS NOT RETURNED FOR INSPECTION. 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. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO UNAUTHORIZED DEVIATIONS OR NON-CONFORMANCES WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT WERE DOCUMENTED AS PART OF THE DHR. LOT WAS INSPECTED AND ACCEPTED BY QA. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, D3: MANUFACTURER, D4: DEVICE EXPIRATION, D4: UDI NUMBER IS N/A, D10: DEVICE AVAILABILITY, G2: MANUFACTURER'S CONTACT OFFICE, G4: DATE RECEIVED BY MANUFACTURER, G7: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H3: CHANGED "NO" TO "YES", H4: DATE OF MANUFACTURE, H6: ENTERED EVALUATION CODES, H10: 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). PATIENT'S WEIGHT NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBERS: K113753 AND K112160. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT ((B)(4)) FRACTURED NEAR THE COLLAR. THE LOWER PORTION OF THE IMPLANT REMAINS IMPLANTED. REMOVAL OF THE IMPLANT HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756538 IMP TM 4.1MM MTX FULL,13M DENTAL IMPLANT DZE ZIMMER DENTAL 61926106

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR