BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SINGLE INNER SET SCREW

    MDR report key: 2103730 · Received May 16, 2011

    Report

    Report Number
    1526439-2011-00077
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 20, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K033901
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT IS TIGHTENED PROPERLY. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    CONTACT REPORTS THAT FOUR EXPEDIUM SINGLE INNER SET SCREWS, ALL LOT AMBCL4, ON THE LEFT SIDE OF THE CONSTRUCT LOOSENED IN SITU AND THE ROD ON THAT SIDE SLIPPED. REVISION SURGERY WAS PERFORMED TO REPLACE THE SET SCREWS AS WELL AS THE CONCOMITANT DEVICE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SINGLE INNER SET SCREW SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA AMBCL4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EXPEDIUM ROD: (B)(4), QTY = 1| EXPEDIUM POLYAXIAL SCREW: (B)(4), QTY = 2| TORQUE WRENCH HANDLE: (B)(4), QTY = 1