BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2192150 · Received August 4, 2011

    Report

    Report Number
    1030489-2011-01006
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICAL THERAPIST

    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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SURGERY AT L5-S1 WITH RHBMP-2/ACS. 8 WEEKS POST-OP, THE PATIENT RETURNED TO THE HOSPITAL FOR EMERGENCY SURGERY DUE TO "AN EXCESSIVE AMOUNT OF ECTOPIC BONE GROWTH SURROUNDING THE DURAL SAC AND UP THROUGH MY SPINAL CANAL." THE L5-S1 NERVE WAS CUT, CREATING PERMANENT NERVE DAMAGE, PAIN AND NUMBNESS TO THE TOES. THE DURAL SAC WAS CUT CREATING A LARGE CSF LEAK WHICH LEFT THE PATIENT WITH A 4CM CYST WITHIN THE SPINAL CANAL WHICH TOOK 1.5 YEARS TO DISSOLVE CREATING EVEN MORE EXTREME PAIN. THE PATIENT UNDERWENT A THIRD SURGERY TO TRY TO CORRECT MORE DAMAGE. THE PATIENT HAS SINCE UNDERGONE "AT LEAST 2 MORE SURGERIES TO PREVENT FURTHER NERVE DAMAGE AND DISABILITY." REPORTEDLY, THE BONE CONTINUES TO GROW 4 YEARS LATER. THE PATIENT IS IN SEVERE PAIN THROUGHOUT THE BACK AND BOTH LOWER EXTREMITIES TO TOES WITH ONE SIDE COMPLETELY NUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00042 YR Required Intervention| S