BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM X 40MM MULTIAXIAL ILIAC SCREW

    MDR report key: 7026402 · Received November 13, 2017

    Report

    Report Number
    3012447612-2017-00624
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Report Date
    November 13, 2017
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    PMA / PMN Number
    PK061441
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW WAS DISCARDED AT THE HOSPITAL. SINCE THE SCREW WAS NOT RETURNED FOR EVALUATION, NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN PRECAUTIONS AGAINST REUSING ANY IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDICLE SCREW LOST ITS MUTIAXIAL CAPABILITIES DURING SURGERY. THE SCREW AND CLOSURE TOP WERE INSTALLED AND TIGHTENED BUT SUBSEQUENTLY LOOSENED IN ORDER TO CHANGE THE SCREW DIRECTION. AFTER LOOSENING, THE SCREW TULIP WAS FOUND TO REMAIN IN A STATIONARY POSITION WHEN IT WAS ATTEMPTED TO BE REINSERTED. IT WAS REMOVED AND REPLACED WITH AN ALTERNATIVE SCREW. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803623 6.5MM X 40MM MULTIAXIAL ILIAC SCREW EBI 5.5 HELICAL FLANGE SPINAL SYSTEM MNH ZIMMER BIOMET SPINE INC. NA J3967573

    Patients

    Seq Age Sex Outcome Treatment
    1