BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 403424 · Received July 3, 2002

    Report

    Report Number
    1526439-2002-00048
    Event Type
    Other
    Date Received
    July 3, 2002
    Date of Event
    June 17, 2002
    Report Date
    July 3, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A CAGE CRACKED UPON INSERTION. THE SURGEON LEFT THE CAGE IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE LOT NUMBER WAS NOT REPORTED SO NO FURTHER EVALUATION COULD BE PERFORMED. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE PLACED ON THE CAGE DURING INSERTION. 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 THREADED INSERTION HOLES OR DIRECT APPLICATION OF LOADS OF THE THREADED OR SMALL AREA OF THE I/F CAGE COMPONENT CAN SPLIT OR FRACTURE THE CAGE IMPLANTS." SURGEONS SHOULD ENSURE THAT EXCESSIVE TORQUES ARE NOT APPLIED TO THESE DEVICES DURING INSERTION OR MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR I/F CAGE SYSTEM LUMBAR CAGE MCV DEPUY ACROMED, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other