BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VG2 CERVICAL CPK TIP

    MDR report key: 3195885 · Received June 28, 2013

    Report

    Report Number
    1526439-2013-20100
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN X-RAY WAS PROVIDED THAT SHOWED THE PIECE OF METAL THAT WAS REPORTED TO BE POSTERIOR TO THE GRAFT. VISUAL INSPECTION OF THE INSTRUMENT FOUND THAT ONE OF THE TAPERED SUPPORT PINS WAS SEPARATED FROM THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO COMPLAINTS WERE REPORTED FOR THIS PRODUCT CODE AND LOT NUMBER WITHIN THE PAST TWELVE MONTHS. THE ROOT CAUSE IS UNDETERMINED. HOWEVER, THE NOTED DAMAGE SUGGESTS THAT THE PIN WELD MAY HAVE BEEN SUBJECTED TO AN UNANTICIPATED LEVEL OF STRESS RESULTING IN SEPARATION. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO VG1 GRAFTS WERE IMPLANTED, ONE AT C5-6 AND ONE AT C6-7, A/P AND LATERAL C-ARM IMAGES TAKEN. ON BOTH VIEWS, POSTERIOR TO THE C6-7 GRAFT WAS A ¿DOT¿, INDICATING THAT A PIECE OF METAL WAS POSITIONED POSTERIOR TO THE GRAFT. ADDITIONAL IMAGES WERE TAKEN AND THE GRAFT AT C6-7 WAS REMOVED ALONG WITH A PIECE OF METAL FROM THE DISC SPACE. EXAMINATION OF THE METAL PIECE DETERMINED IT WAS THE TIP THAT HAD BROKEN OFF FROM THE VG2 INSERTER. THE GRAFT WAS REINSERTED AND THE PROCEDURE WAS COMPLETED. THE DIFFICULTY RESULTED IN A DELAY TO THE PROCEDURE OF FIFTEEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295200 VG2 CERVICAL CPK TIP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE R0511

    Patients

    Seq Age Sex Outcome Treatment
    1