BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW 45

    MDR report key: 2162127 · Received July 7, 2011

    Report

    Report Number
    3004142400-2011-00017
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NQP
    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 EVALUATION; HOWEVER, A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTIONS 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. BASED ON RECORD REVIEW OF ALL AVAILABLE INFORMATION, IT IS DETERMINED THE TRANSITION 6.5MM POLYAXIAL PEDICLE SCREW, 45MM DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURING PROCESS. THERE IS NO INDICATION THAT THE ISSUE WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6), 2011 OF A BROKEN TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW 45MM THAT BROKE AT L2 LEFT SIDE POST-OPERATIVELY, ORIGINALLY IMPLANTED ON (B)(6), 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW 45 TRANSITION 6.5MM POLYAXIAL PEDICLE SCREW NQP GLOBUS MEDICAL, INC. 152.465S GBK061JC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention TRANSITION BUILDABLE ROD IMPLANT