BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE TWO:5.5MM REVERE PEDICLE SCREW

    MDR report key: 2823546 · Received June 18, 2009

    Report

    Report Number
    3004142400-2009-00009
    Event Type
    Injury
    Date Received
    June 18, 2009
    Date of Event
    May 19, 2009
    Report Date
    May 19, 2009
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MNH
    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. A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. ADDITIONALLY, A SISTER-DEVICE FROM THE SAME LOT WAS EVALUATED AND DETERMINED TO MEET SPECS. BASED ON A SECOND REVIEW AND ALL AVAILABLE INFO, IT IS DETERMINED THE XPAND CORPECTOMY SPACER MEDIUM 21X23 -3/3 DEGREES 37-46MME DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THAT THE ISSUE WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    GLOBUS MEDICAL INC. RECEIVED NOTIFICATION FROM A SALES REP, VIA TELEPHONE COMMUNICATION, THAT ONE (1) GLOBUS MANUFACTURED SPACER HAD COLLAPSED AND ONE (1) PEDICLE SCREW HAD BROKEN AFTER IMPLANTATION. ON (B)(6) 2008, A FEMALE PT UNDERWENT SPONDYLECTOMY SURGERY DURING WHICH A REVERE PEDICLE SCREW AND XPAND CORPECTOMY SPACER WERE IMPLANTED. ON (B)(6) 2009, THE PT HAD F/U X-RAYS THAT SHOWED A BROKEN SCREW ON THE LEFT SIDE AT S1 AND A COLLAPSED L4-S1 INTERVERTEBRAL CAGE. THE PT EXPERIENCED A FALL FROM A CHAIR A FEW WEEKS PRIOR TO THE F/U. REVISION SURGERY WAS PERFORMED ON (B)(6) 2009, AND THE SURGEON REMOVED THE REVERE SCREW, BUT DID NOT REMOVE THE XPAND SPACER DUE TO SCAR TISSUE. ADD'L SCREWS WERE PROVIDED AT L3-4 AND S1-2. GLOBUS MEDICAL INC. WAS NOTIFIED OF THE COMPLAINT ON (B)(4) 2009 BY A GLOBUS MEDICAL, INC. REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE TWO:5.5MM REVERE PEDICLE SCREW DEVICE TWO: REVERE PEDICLE SCREW MNH GLOBUS MEDICAL, INC. 124.456 GMG191JE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DEVICE ONE: XPAND CORPECTOMY SPACER MEDIUM 21X23| -3/3 DEGREES 37-46MME