BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 387297 · Received April 8, 2002

    Report

    Report Number
    1526439-2002-00020
    Event Type
    Other
    Date Received
    April 8, 2002
    Date of Event
    March 6, 2002
    Report Date
    April 8, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MAX
    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. THE INITIAL IMPLANT DATE IS IN 2001 AND THE CAGE WAS EXPLANTED IN 2002. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ARCOMED THAT A LUMBAR I/F CAGE WAS EXPANTED FROM A PT DUE TO A POTENTIAL PSEUDARTHROSIS. ACCORDING TO THE COMPLAINANT, THE NUMBER OF LEVELS INSTRUMENTED WERE EXTENDED DURING THE REVISION SURGERY. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PT. THE CAGE WAS SENT TO DR. BAUER FOR A HISTOLOGICAL EVAL PER THE PMA APPROVAL REQUIREMENT. THE CAGE WAS NOT RETURNED TO DEPUY ACROMED. THE LOT NUMBER ETCHED ON THE IMPLANT COULD NOT BE READ BY THE COMPLAINANT. NO FURTHER EVAL COULD BE PERFORMED. AS STATED BY THE COMPLAINANT, THE MOST LIKELY CAUSE OF THE EVENT IS A PSEUDARTHROSIS. THE LABELING PROVIDED WITH THE LUMBAR I/F CAGE CAUTIONS THAT A DELAYED UNION OR A NONUNION IS A POSSIBLE ADVERSE EFFECT. NO FURTHER ACTION IS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other