BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM REVERE PEDICLE SCREW 50MM

    MDR report key: 2495984 · Received March 15, 2012

    Report

    Report Number
    3004142400-2012-00004
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 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 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 6.5MM REVERE PEDICLE SCREW 50MM 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. THE DATE OF MANUFACTURE CANNOT BE DETERMINED WITHOUT LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY TOOK PLACE (B)(6) 2012 TO REMOVE TWO BROKEN REVERE PEDICLE SCREWS FROM PT. INITIAL SURGERY TOOK PLACE APPROXIMATELY 1.5 - 2 YEARS AGO. ORIGINAL CONSTRUCT WAS AN L4-S1 FUSION WITH REVERE SCREWS AND TRANSITION 2 LEVEL PRE-CONSTRUCTED RODS. REVISION SURGERY WAS NEEDED DUE TO L4 BILATERAL SCREW BREAKAGE. BOTH BREAKS WERE MID THREAD NEAR THE PEDICLE/POSTERIOR ASPECT OF THE VERTEBRAL BODY. THERE WERE NO COMPLICATIONS DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM REVERE PEDICLE SCREW 50MM 6.5MM REVERE PEDICLE SCREW NQP GLOBUS MEDICAL, INC. 124.466

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention