BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERE PEDICLE SCREW

    MDR report key: 4091235 · Received August 18, 2014

    Report

    Report Number
    3004142400-2014-00039
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    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, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS NO PART NUMBER OR LOT NUMBER WAS PROVIDED. IT HAS BEEN REPORTED PT WILL UNDERGO A REVISION SURGERY ON (B)(6) 2014. GLOBUS WILL PROVIDE A SUPPLEMENTAL REPORT WHEN ADDITIONAL INFO IS OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GLOBUS THAT A PT HAD BENT OVER TO PICK SOMETHING UP, AND HEARD A "POP". PT HAD X-RAYS TAKEN AND IT WAS CONFIRMED THE LEFT L2 SCREW HAD BROKEN. A REVISION SURGERY HAS BEEN SCHEDULED BUT HAS NOT YET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496277 REVERE PEDICLE SCREW REVERE PEDICLE SCREW MQP GLOBUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R