BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 2942812 · Received February 5, 2013

    Report

    Report Number
    0009617544-2013-00007
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    May 11, 2009
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2009 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF HERNIATED DISC, INCLUDING SEGMENTAL INTERNAL FIXATION, DURING WHICH A STRYKER XIA POLYAXIAL PEDICLE SCREW AS PLACED AT THE S1 LEVEL. IT IS FURTHER ALLEGED THAT FOLLOWING SURGERY, THE PEDICLE SCREW BECAME DISLODGED, NECESSITATING A SECOND SURGERY ON (B)(6) 2009 TO REPLACE THE PEDICLE SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48313 UNKNOWN_SPINE_PRODUCT PEDICLE SCREW MNH STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention