BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIPHOS INTERBODY FUSION SYSTEM

    MDR report key: 2724566 · Received August 30, 2012

    Report

    Report Number
    3009336374-2012-00001
    Event Type
    Injury
    Date Received
    August 30, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    Manufacturer
    DIFUSION TECHNOLOGIES
    Product Code
    MAX
    PMA / PMN Number
    K100042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE 30MM X 09MM TLIF IMPLANTS (P/N 300-3009) ARE INCLUDED IN THE XIPHOS IBFD SYSTEM. IT WAS REPORTED THAT DURING SURGERY ONE (1) 09 MM TLIF IMPLANT FROM LOT# 16019-2-1 FRACTURED. PRIOR TO IMPLANTATION, THE SURGEON REMOVED THE SILICONE MATERIAL ENVELOPING THE HANDLE OF THE TLIF INSERTER (P/N 900-2000) TO ACHIEVE METAL IMPACTION. THE SURGEON THEN PROCEEDED TO SECURE THE IMPLANT INTO THE DISC SPACE BY IMPACTING THE INSERTER HANDLE. FOLLOWING IMPACTION, THE SURGEON COULD SEE THE 09 MM TLIF IMPLANT HAD FRACTURED. THE SURGEON THEN REMOVED THE FRACTURED IMPLANT FROM THE DISC SPACE. ONCE THE DEVICE WAS SUCCESSFULLY EXPLANTED, AN 08 MM IMPLANT OF A DIFFERENT MANUFACTURER'S LOT WAS SUCCESSFULLY IMPLANTED IN THE DISC SPACE. THE DELAY IN SURGERY WAS NO MORE THAN FIVE (5) MINS. IN ACCORDANCE WITH HOSPITAL POLICY, THE FRACTURED IMPLANT WAS NOT RETURNED TO THE MANUFACTURER. THE TLIF INSERTER, HOWEVER, WILL BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIPHOS INTERBODY FUSION SYSTEM MAX, MQP MAX DIFUSION TECHNOLOGIES 16019-2-1

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR