BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM ULTRA ROD 5.5X700MM

    MDR report key: 2212705 · Received August 11, 2011

    Report

    Report Number
    1526439-2011-00137
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    February 26, 2011
    Manufacturer
    DEPUY SPINE INC.
    Product Code
    KWP
    PMA / PMN Number
    K041119
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. NO CONCLUSIONS CAN BE MADE AT THIS TIME. DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION, AND BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION, AS WELL AS 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

    LETTER RECEIVED REPORTING POST-OP ROD BREAKAGE. IN SUMMARY A PATIENT WAS IMPLANTED WITH XPDM HARDWARE T2-PELVIS IN (B)(6) 2009. IN (B)(6) 2011, PATIENT HEARD A POP. X-RAY FOUND FRACTURED ROD AT L4-L5. REVISED (B)(6) 2011 FOR HARDWARE REMOVAL AND RE-INSTRUMENTATION FROM T11-PELVIS. CONTACT REPORTED THAT THEY HAVE NOTIFIED THE MANUFACTURER, DEPUY SPINE AND THE FDA ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM ULTRA ROD 5.5X700MM SPINAL FIXATION DEVICE KWP DEPUY SPINE INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention