BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1963029 · Received January 18, 2011

    Report

    Report Number
    1030489-2011-00060
    Event Type
    Injury
    Date Received
    January 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-5 POSTERIOR FUSION USING RHBMP-2/ACS AND POSTERIOR INSTRUMENTATION. AT AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED RIGHT LOWER EXTREMITY RADICULOPATHY. 48 DAYS POST-OP, THE PATIENT UNDERWENT A REINSTRUMENTATION SURGERY WHICH SUCCESSFULLY RID THE PATIENT OF THE LOWER EXTREMITY PAIN. THE PATIENT RETURNED TO WORK APPROXIMATELY 4 MONTHS LATER, BUT HAS DEVELOPED BILATERAL RADICULOPATHY AND FASCICULATIONS IN THE LAST SEVERAL MONTHS. THE PATIENT HAD CT, MRI AND CT/MYELOGRAM. NO BONE IS SEEN IN THE FORAMEN OR CANAL AND NO REASON WAS SEEN FOR THE RADICULOPATHY EXCEPT THAT THERE MAY NOT BE COMPLETE BRIDGING BONE. THE PATIENT IS CONSIDERING ADDITIONAL SURGERY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-5 FUSION USING RHBMP-2/ACS AND INSTRUMENTATION. AT AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED RIGHT LOWER EXTREMITY RADICULOPATHY. AT 48 DAYS POST-OP, THE PATIENT UNDERWENT AN ANTERIOR REINSTRUMENTATION SURGERY TO REPLACE A MALPOSITIONED WHICH SUCCESSFULLY RID THE PATIENT OF THE LOWER EXTREMITY PAIN. THE PATIENT DEVELOPED SEXUAL DYSFUNCTION AFTER THIS REVISION SURGERY, WHICH WAS DIAGNOSED AS AN ABSENT FEMALE VASOMOTOR RESPONSE AS A RESULT OF AUTONOMOUS PLEXUS INJURY. THE PATIENT RETURNED TO WORK APPROXIMATELY 4 MONTHS LATER, BUT HAS DEVELOPED BILATERAL RADICULOPATHY AND FASCICULATIONS IN THE LAST SEVERAL MONTHS. THE PATIENT HAD CT, MRI AND CT/MYELOGRAM. NO BONE IS SEEN IN THE FORAMEN OR CANAL AND NO REASON WAS SEEN FOR THE RADICULOPATHY EXCEPT THAT THERE MAY NOT BE COMPLETE BRIDGING BONE. THE PATIENT'S BACK PAIN AND LEG PAIN RETURNED AND SHE HAD A SURGERY BY ANOTHER SURGEON WHO DIAGNOSED HER WITH AN L5 NERVE ROOT OCCLUSION AND LOCKED NON-UNION, AND PERFORMED A PLIF SURGERY WITH ILIAC CREST BONE APPROXIMATELY 16 MONTHS AFTER THE INITIAL FUSION SURGERY. THE PATIENT REPORTS GENERALIZED FASCICULATION, STARTING WITH SOME MUSCLE TWITCHING. ANOTHER SURGEON HAS DIAGNOSED FAILED FUSION, FASCICULATION DISORDER AND SEXUAL DYSFUNCTION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R| S