BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTEX OPENER

    MDR report key: 1061565 · Received June 17, 2008

    Report

    Report Number
    1719045-2008-00078
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 29, 2008
    Manufacturer
    SYNTHES MONUMENT(USA)
    Product Code
    MAX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    WHILE INSTRUMENTING SYNFIX-LR CASE FOR ALIF, THE ILIAC VEIN WAS COMPROMISED. THE SYNTHES CORTEX OPENER FOR SYNFIX-LR WAS USED WITHOUT THE AIMING ARM, ALONG WITH A COMPETITOR'S DEVICE (ANTERIOR LUMBAR RETRACTION SYSTEM). THE SURGEON BELIEVES THE RETRACTOR MAY HAVE COMPROMISED THE VEIN, NOT THE SYNTHES CORTEX OPENER. THE SURGEON REPAIRED THE VEIN AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTEX OPENER CORTEX OPENER FOR SYNFIX-LR MAX SYNTHES MONUMENT(USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention