BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR I/F CAGE PEAK 9X9X25MM

    MDR report key: 1645632 · Received March 19, 2010

    Report

    Report Number
    1526439-2010-00048
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 22, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    P960025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN FRAGMENT OF THE CAGE HAS NOT YET BEEN RETURNED FOR EVAL. IF IT IS RETURNED IT IS LIKELY THAT A USEFUL ANALYSIS WILL BE ABLE TO BE PERFORMED. BASED ON THE DESCRIPTION OF THE EVENT, IT APPEARS THAT THE CAGE MAY HAVE BEEN INSERTED TOO FAR POSTERIOR AND WHEN BEING PULLED BACK A PORTION OF THE CAGE BROKE OFF. THE REMAINING PORTION OF THE CAGE WAS LEFT IN PLACE. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE PLACED ON THE CAGE TRYING TO PULL THE CAGE BACK. THIS TYPE OF EVENT IS NOT UNANTICIPATED AS THE INSTRUCTIONS FOR USE CONTAINED IN THE PACKAGING OF THIS PRODUCT STATES THAT EXCESSIVE TORQUE APPLIED TO THE LONG-HANDLE INSERTION TOOLS ATTACHED TO THE INSERTION HOLES OR DIRECT APPLICATION OF LOADS OF THE THREADED OR SMALL AREA OF THE CAGE COMPONENT CAN SPLIT OR FRACTURE THE CAGE IMPLANTS.

    Description of Event or Problem · 1

    L3-5 INSTRUMENTATION WAS DONE FOR CONGENITAL SCOLIOSIS. DURING SURGERY, THE CAGE USED FOR L3-L4 GOT INTO THE BODY OF THE VERTEBRA. WHEN THE DOCTOR TRIED TO REMOVE THE CAGE, PART OF THE CAGE WAS BROKEN. THE CAGE STILL REMAINS IN THE PT'S BODY. WE WILL LET YOU KNOW THE LOT NUMBER OF THE DEVICE AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR I/F CAGE PEAK 9X9X25MM VBA DEVICE MAX DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK