BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2402044 · Received January 6, 2012

    Report

    Report Number
    1030489-2012-00018
    Event Type
    Injury
    Date Received
    January 6, 2012
    Report Date
    December 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: RONALD A. LEHMAN, JR., MD. VERTEBRAL BODY OSTEOLYSIS AFTER MINIMAL-ACCESS TRANSFORAMINAL INTERBODY FUSION. THE SPINE JOURNAL 11 (2011) 581-582. (B)(4) RADICULITIS. (B)(4). REVIEW WAS PERFORMED OF AP, LATERAL AND AXIAL CT IMAGES OF L4-5 LEVEL REPORTEDLY TREATED WITH CAPSTONE, RHBMP, AND PEDICLE SCREWS AT L4 AND L5. OSTEOLYSIS AND SCLEROSIS ARE NOTED AROUND A CAPSTONE SPACER SEEN BEST ON CORONAL VIEWS. OSTEOLYSIS IS SEEN ON SAGITTAL VIEW BEST. THE DEVICE WAS NOT 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. MULTIPLE PRODUCTS 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 IN A LITERATURE PUBLICATION THAT THE PATIENT PREVIOUSLY UNDERWENT AN L5-S1 FUSION AND DEVELOPED SUPRAJACENT DEGENERATION AND RADICULOPATHY. THE PATIENT UNDERWENT A MINIMAL-ACCESS TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH A CAGE FILLED WITH 6 MG OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 ON AN ABSORBABLE COLLAGEN SPONGE (RHBMP-2/ACS) INSERTED FROM THE LEFT SIDE. SHE SUBSEQUENTLY DEVELOPED POSTOPERATIVE LEFT LOWER EXTREMITY RADICULITIS THAT WAS REFRACTORY TO NARCOTICS AND GABAPENTIN SEVERAL MONTHS AFTER THE SURGERY. CT SCANS TAKEN 6 MONTHS POST-OPERATIVELY DEMONSTRATED VERTEBRAL BOSY OSTEOLYSIS.

    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 00063 YR Required Intervention