BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 10 MM

    MDR report key: 9716468 · Received February 17, 2020

    Report

    Report Number
    0002023141-2020-00318
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 10, 2020
    Report Date
    April 15, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPLANT WAS RETURNED WITH ITS RESPECTIVE MOUNT FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE AND WEAR ALONG THE THREADS/HA COATING AND THE TINES WERE NOT FULLY MATES. IT WAS DETERMINED THE DEVICE FAILED FUNCTIONAL TESTING AS THE MOUNT COULD NOT BE REMOVED FROM THE IMPLANT. 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: B4: DATE OF THIS REPORT D4: DEVICE EXPIRATION. D4: UDI. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES." 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

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT AGE AND WEIGHT NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K962106. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUNDLED MOUNT AND IMPLANT COULD NOT BE DISENGAGED FROM EACH OTHER. ANOTHER IMPLANT WAS PLACED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181258 IMPL TWIST MP-1 5.0 MM 10 MM DENTAL IMPANT DZE ZIMMER DENTAL 2018090237

    Patients

    Seq Age Sex Outcome Treatment
    1