BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SCREW 7.0 X 45

    MDR report key: 2143041 · Received June 23, 2011

    Report

    Report Number
    1526439-2011-00111
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 3, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED THE RETURN OF THE BROKEN SCREW FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS PT HEARD A CLICKING SOUND WHEN LAYING DOWN BUT HAD NO PAIN OR NEUROLOGICAL SYMPTOMS. MRI REVEALED THAT ONE PEDICLE SCREW WAS BROKEN. DURING REVISION SURGERY IT WAS NOTED THAT BOTH THE LEFT AND RIGHT SIDED SCREWS AT THE S1 LEVEL WERE COMPLETELY SHEARED. THE DEVICES WERE IMPLANTED IN 2008, THE EXACT DATE UNK. SEE MFG MEDWATCH REPORT NO. 1526439-2011-00110 FOR THE OTHER SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SCREW 7.0 X 45 SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Female Required Intervention