BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4171459 · Received October 14, 2014

    Report

    Report Number
    1030489-2014-04032
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT PRESENTED HAVING HAD A FALL A COUPLE OF DAYS AGO IN HIS HOME. HIS LEG GAVE OUT AND HE FELL ONTO A HARDWOOD FLOOR. PATIENT STATES THAT HE LOST CONSCIOUSNESS AT THAT TIME. HE WENT TO THE ER AND HAD A CT SCAN AND X-RAYS PERFORMED. HIS PAIN IS WORSE SINCE THAT TIME WITH PAIN DOWN INTO HIS BILATERAL LOWER EXTREMITIES. HE AMBULATES USING A WALKER. PER THE PHYSICIAN¿S NOTES, ¿TODAY ON PHYSICAL EXAM, THE PATIENT HAS A NARROW-BASED GAIT. HIS NEUROVASCULAR EXAM IS UNCHANGED COMPARED TO PRIOR VISITS.¿ CT SCAN DATED (B)(6) 2010 INDICATED ¿SOME HALOS AROUND HIS L3 SCREWS BILATERALLY. HIS L4 SCREW ON THE LEFT SIDE IS JUST WITHIN THE LATERAL CONFINES OF THE PEDICLE; OTHERWISE, HARDWARE IS HOLDING IN ALIGNMENT. MILD BONY OVERGROWTH TO THE RIGHT SIDE AT L5-S1; OTHERWISE I DO NOT SEE ANY OVERT SEVERE STENOSIS. AS I REVIEW HIS CT SCAN, IT DOES APPEAR THERE IS SOME GRAFT INCORPORATION IN THE POSTEROLATERAL REGION. IT JUST DOES NOT APPEAR COMPLETELY SOLID INDICATING A PSEUDOARTHROSIS AT MINIMUM AT THE L3-4 LEVEL. I AM NOT SURE ABOUT THE L4-5 OR L5-S1 LEVELS.¿ IT WAS REPORTED THAT THE PATIENT DEVELOPED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650564 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 Other