BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSITION 2 LEVEL IMPLANT, LORDOSED, 28MM

    MDR report key: 2800432 · Received October 16, 2012

    Report

    Report Number
    3004142400-2012-00023
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 16, 2012
    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 EVAL, HOWEVER, A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MFG 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 SPECS, MAINTAINED, AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON RECORD REVIEW OF ALL AVAILABLE INFO, IT IS DETERMINED THE TRANSITION 2 LEVEL IMPLANT, LORDOSED, 28MM DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO INDICATION THAT THE ISSUE WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GLOBUS THAT A REVISION SURGERY WAS NECESSARY TO REMOVE A BROKEN TRANSITION ROD. INITIAL SURGERY TOOK PLACE (B)(6) 2011. TRANSITION WAS USED AT L3-S1. PT CAME BACK WITH SOME PAIN, AND X-RAYS WERE TAKEN. X-RAYS DID NOT REVEAL ANY ABNORMALITIES. DOCTOR DECIDED TO PERFORM REVISION SURGERY TO ALLEVIATE THE PAIN. IN SITU HE NOTICED A BROKEN ROD, WHICH HE REMOVED. HE THEN REVISED WITH RIGID INSTRUMENTATION FROM L2-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSITION 2 LEVEL IMPLANT, LORDOSED, 28MM TRANSITION IMPLANT NQP GLOBUS MEDICAL, INC. 152.018S

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention