BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 380990 · Received March 7, 2002

    Report

    Report Number
    1526439-2002-00011
    Event Type
    Other
    Date Received
    March 7, 2002
    Report Date
    March 7, 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 LUMBAR I/F CAGE BROKE POST-OPERATIVELY. AN EXPLANT SURGERY WAS REQUIRED TO REMOVE THE BROKEN CAGE. ACCORDING TO THE COMPLAINANT, ONLY ONE CAGE WAS USED AND IT WAS PLACED AT AN OBLIQUE ANGLE IN THE DISC SPACE. THE INITIAL IMPLANT DATE WAS NOT REPORTED. THE CAGE WAS NOT RETURNED FOR EVAL. NUMEROUS ATTEMPTS WERE MADE FOR MORE INFO CONCERNING THE RETURN OF THE CAGE, BUT THEY WERE UNSUCCESSFUL. THERE WERE NO CAGES REMAINING IN INVENTORY CONTAINING THIS PART/LOT NUMBER COMBINATION. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED. IT IS RECOMMENDED IN THE LABELING THAT TWO LUMBAR I/F CAGES BE USED PER LEVEL. THE SURGEON IN THIS CASE USED ONLY ONE CAGE WHICH MAY HAVE PLACED ADDITIONAL STRESS ON THE CAGE, CONTRIBUTING TO THE EVENT. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A LUMBAR I/F CAGE BROKE POST-OPERATIVELY. THE INITIAL IMPLANT DATE WAS NOT REPORTED BY THE COMPLAINANT. AN EXPLANT SURGERY WAS REQUIRED BUT THE DATE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A LUMBAR I/F CAGE BROKE POST-OPERATIVELY. ADDITIONAL INFO FROM THE COMPLAINANT REVEALED THAT THE INITIAL DATE WAS REPORTED AS 5/16/2001 AND THE CAGE WAS EXPLANTED ON 2/5/2002. THE COMPLAINANT ALSO REPORTED THAT THE PT HAD A PSEUDOARTHROSIS. A DIMENSIONAL ANALYSIS OR FRACTURE ANALYSIS COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE CAGE. THE CAGE BROKE INTO NUMEROUS SMALL PIECES DURING REMOVAL. THE RETURNED CAGE HAD BEEN CLEANED SO A HISTOLOGICAL ANALYSIS COULD NOT BE PERFORMED AS REQUIRED BY THE CONDITIONS OF THE PMA APPROVAL. ADDITIONAL INFO REPORTED BY THE COMPLAINANT SUGGESTS THAT THE MOST LIKELY CAUSE OF THE CAGE BREAKAGE IS PSEUDOARTHROSIS. THE PSEUDOARTHROSIS WOULD PLACE EXCESSIVE FORCES ON THE THE CAGE, CAUSING IT TO BREAK. THE LABELING CONTAINED WITH THE DEVICE WARNS AGAINST SUCH EVENTS. NO FURTHER ACTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR I/F CAGE SYSTEM LUMBAR CAGE MCV DEPUY ACROMED, INC. NA 5C25B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other