BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 402211 · Received June 27, 2002

    Report

    Report Number
    1526439-2002-00046
    Event Type
    Other
    Date Received
    June 27, 2002
    Report Date
    June 27, 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 THE BASE OF THE CAGE BROKE OFF FROM THE STRUTS OF THE CAGE. ACCORDING TO THE COMPLAINANT, THE CAGE WAS IMPACTED TOO FAR ANTERIORLY AND THE SURGEON WANTED TO BACK THE CAGE OUT SLIGHTLY AND THE BACK END OF THE CAGE BROKE OFF FROM THE STRUTS. THE SURGEON LEFT THE CAGE IMPLANTED. THE BASE OF THE CAGE WAS DISCARDED BY THE HOSP. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. THE COMPLAINANT DID NOT REPORT THE LOT NUMBER AND THE BASE OF THE CAGE WAS NOT RETURNED FOR EVALUATION. NO FURTHER EVALUATION COULD BE PERFORMED. THE MOSTLY LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE PLACED ON THE CAGE DURING MANIPULATION. THIS TYPE OF EVENT IS NOT UNANTICIPATED AS THE INSTRUCTIONS FOR USE CONTAINED IN THE PACKAGING OF THIS PRODUCT STATE THAT "EXCESSIVE TORQUE 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