BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSS MIAMI 6.0 X 50MM POLYAXIAL SCREW

    MDR report key: 2161922 · Received July 11, 2011

    Report

    Report Number
    1526439-2011-00120
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    November 1, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K030383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION. BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION AS WELL AS WITH CYCLICAL LOADING OF THE DEVICE OVER TIME. NOTCHES, SCRATCHES OR BENDING OF THE IMPLANT DURING THE COURSE OF SURGERY MAY ALSO CONTRIBUTE TO EARLY FAILURE. THESE PRECAUTIONS ARE STATED IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS PATIENT HAD A GIANT CELL TUMOR OF THE SACRUM. SPINAL DEVICES WERE IMPLANTED IN (B)(6) 2009. IN (B)(6) 20210, THE PATIENT FELT PAIN AND X-RAYS REVEALED THAT THE POLYAXIAL SCREW HAD BROKEN IN SITU. REVISION SURGERY WAS PERFORMED AND THE BROKEN SCREW WAS REMOVED. THE EVENT WAS REPORTED TO A JOHNSON & JOHNSON REPRESENTATIVE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSS MIAMI 6.0 X 50MM POLYAXIAL SCREW SPINAL FIXATION DEVICE MNH DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention