BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2474501 · Received March 1, 2012

    Report

    Report Number
    1030489-2012-00218
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    February 10, 2011
    Report Date
    January 31, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: DEYO ET AL. USE OF BONE MORPHOGENETIC PROTEINS WITH SPINAL FUSION SURGERY FOR OLDER ADULTS WITH LUMBAR STENOSIS. SPINE. 2012: 37; 3: 222-230. 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. (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 IN A LITERATURE PUBLICATION THAT A RETROSPECTIVE COHORT STUDY WAS CONDUCTED OF MEDICARE CLAIMS. PATIENTS WITH A PRIMARY DIAGNOSIS OF LUMBAR STENOSIS (98.2% OF CASES) OR "SPONDYLOGENIC COMPRESSION OF LUMBAR SPINAL CORD" (1.8% OF CASES) WHO UNDERWENT FUSION SURGERY WERE IDENTIFIED FOR THIS STUDY. PATIENTS WERE IDENTIFIED AS HAVING HAD BMP USED IN THE FUSION PROCEDURE (1703 PTS) OR AS HAVING HAD THE FUSION PERFORMED WITHOUT BMP (15119 PTS). FORTY PATIENTS DEVELOPED WOUND COMPLICATIONS POSTOPERATIVELY. WOUND COMPLICATIONS WERE DEFINED BY THE AUTHORS AS INCLUDING HEMORRHAGE, HEMATOMA OR SEROMA COMPLICATING A PROCEDURE, DISRUPTION OF OPERATION WOUND, NON-HEALING SURGICAL WOUND, POSTOPERATIVE INFECTION, OTHER INFECTION, EXCISIONAL DEBRIDEMENT, AND WOUND DEBRIDEMENT.

    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 Required Intervention