BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE ONE: CERVICAL INSTRUMENT CHISEL, 7MM

    MDR report key: 3076503 · Received April 22, 2013

    Report

    Report Number
    3004142400-2013-00004
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVAL; HOWEVER, A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTION OF THE PRODUCT USED WITH THE CONCOMITANT DEVICE. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THERE WAS NO FAILURE OF INSTRUMENTATION REPORTED. INSTRUMENT IS NOT AVAILABLE FOR EVAL. THERE HAVE BEEN NO PREVIOUS COMPLAINTS ON THIS INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GLOBUS BY A SALES REP THAT DURING A SURGERY, UPON IMPACTION OF THE BROACHING CHISEL (7MM) OVER A 7MM TRIAL (14 X 16 MM, 6 DEGREES) THE INSTRUMENTS WERE PUSHED TOO FAR POSTERIOR INTO THE SPINAL CANAL. THE INSTRUMENTS MADE CONTACT WITH THE SPINAL CORD AND RESULTED IN WHAT APPEARS TO BE A SPINAL CORD INJURY. A TWO LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WAS PERFORMED WITH A CERVICAL PLATE AND INTERBODY SPACERS TO FUSE THE SEGMENTS OF THE SPINE, C5 - C7. THIS PROCEDURE WAS PERFORMED IN LIEU OF THE ORIGINALLY PLANNED SURGERY. ORIGINAL PLANNED SURGERY WAS GOING TO BE A 1 LEVEL CERVICAL FUSION C6 - C7, AND A 1 LEVEL DISC REPLACEMENT C5 - C6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172513 DEVICE ONE: CERVICAL INSTRUMENT CHISEL, 7MM CHISEL, BROACH, 7MM KDG GLOBUS MEDICAL, INC. 614.757 VIL223BB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability