BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 4142540 · Received October 1, 2014

    Report

    Report Number
    3004142400-2014-00047
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    May 21, 2014
    Report Date
    September 19, 2014
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. GLOBUS WILL PROVIDE A SUPPLEMENTAL REPORT WITH THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ON (B)(6) 2014. X-RAY REVEALED LOOSENING OF METALWARE. REVISION SURGERY WAS PERFORMED (B)(6) 2014 TO STABILIZE THE SPINE FROM L4-S1. UPON REVISION BROKEN SCREWS WERE FOUND IN BOTH S1 PEDICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611562 7.5MM REVERE PEDICLE SCREW 40MM 7.5MM REVERE PEDICLE SCREW MNI GLOBUS MEDICAL, INC. 124.474 BGM074EN/BGM125AT

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention TWO 5.5MM CURVED ROD, 55MM