BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW,

    MDR report key: 3142895 · Received May 22, 2013

    Report

    Report Number
    3004142400-2013-00010
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 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 AN OPERATING PROCEDURES. THE COMPLAINT REPORTS THE BREAKAGE OF TRANSITION POLYAXIAL SCREWS. THERE WAS NO REPORTED INCIDENT WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE, NO EXPLANTS WERE RECEIVED FOR ANALYSIS. WE ARE UNABLE TO ASCERTAIN THE EXACT CAUSE OF THE BREAKAGE.

    Description of Event or Problem · 1

    GLOBUS RECEIVED A MEDWATCH REPORT FROM USER FACILITY. IT WAS REPORTED THAT PT WAS EXPERIENCING PAIN IN THE LEFT SACROILIAC AREA. X-RAY REVEALED FRACTURE OF BILATERAL S1 SCREWS. PT UNDERWENT REVISION SURGERY (B)(6) 2013. SCREW SHAFT ON THE RIGHT REMAINS IMPLANTED, THE REST OF THE CONSTRUCT WAS REMOVED AND REPLACED WITH RE-FUSION FROM L2-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226234 TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW, TRANSITION 6.5MM PEDICLE SCREW 45MM NQP GLOBUS MEDICAL, INC. 152.465S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention