BEUDAMED
    FDA Adverse Event Other Summary report: N

    XPAND

    MDR report key: 768064 · Received October 7, 2006

    Report

    Report Number
    3004142400-2006-00002
    Event Type
    Other
    Date Received
    October 7, 2006
    Date of Event
    September 7, 2006
    Report Date
    October 5, 2006
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MQP
    PMA / PMN Number
    k050850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GLOBUS MEDICAL, INC. EVALUATION: PART WAS EVALUATED AND FUNCTIONS AS INTENDED. SET SCREW DOES NOT APPEAR TO HAVE BEEN TIGHTENED. THIS IS THE FIRST SUCH EXPLANTATION FROM THIS PRODUCT FAMILY IN OVER FIVE HUYNDRED (500) IMPLANTATIONS. GLOBUS MEDICAL WILL MONITOR FEEDBACK FOR ANY FURTHER OCCURRENCES. GLOBUS MEDICAL, INC. EVAL: PART WAS EVALUATED AND FUNCTIONS AS INTENDED. SET SCREW DOES NOT APPEAR TO HAVE BEEN TIGHTENED. THIS IS THE FIRST SUCH EXPLANATION FROM THIS PRODUCT FAMILY IN OVER FIVE HUNDRED (500) IMPLANTATIONS. GLOBUS MEDICAL WILL MONITOR FEEDBACK FOR ANY FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    XPAND SMALL 12X14 ODEG 18-23 MME. A PT WAS IMPLANTED IN 2006 WITH ASSURE, PROTEX CT, AND XPAND. THE XPAND IMPLANT WAS A SMALL/PARALLEL IMPLANT (116.102). TWO MONTHS LATER, SALES REPREC'D A CALL FROM DR. SAYING THAT WE NEEDED TO GO TO REMOVE THA XPAND IMPLANT AS HE FELT THAT IT MAY HAVE "COLLAPSED". THE IMPLANT WAS REMOVED ON NEXT DAY AND SENT TO GLOBUS ALONG WITH XRAYS FROM THE IMPLANT DATE AMD EXPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPAND CORPECTOMY SPACER MQP GLOBUS MEDICAL, INC. 116.102 BGF175AE

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention