BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE IMPLANT

    MDR report key: 2822334 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02967
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM AN ATTORNEY REGARDING A PATIENT WHO UNDERWENT A POSTERIOR-LATERAL FUSION AT T4-L3 ON (B)(6) 2011. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2011 TO TREAT A COMPRESSION FRACTURE AT L-4 AND TO CORRECT PEDICLE SCREWS THAT WERE PULLING OUT. THIS IS REPORT #4 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE IMPLANT SPINE IMPLANT GZB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS, SCREWS