BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2991031 · Received March 6, 2013

    Report

    Report Number
    1030489-2013-00679
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL SURGERY USING RHBMP-2/ACS. POST-OP, THE PATIENT REPORTS "HAVING SERIOUS INJURY INCLUDING PAIN AND ANGUISH." REPORTEDLY, "[T]HE DISC HAS MOVED FROM L1-L5 TO SCIATIC NERVE CAUSING NERVE DAMAGE AND PAIN THAT FEELS LIKE PINS AND NEEDLES GOING FROM HIS RIGHT LEG TO HIS FOOT. NERVE DAMAGE ALSO AFFECTING HIS SEXUAL ACTIVITIES AND HE CAN NO LONGER FUNCTION ON THE SAME LEVEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95698 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention