BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4813366 · Received June 2, 2015

    Report

    Report Number
    1030489-2015-01102
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: 2006. (B)(6). (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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOLLOWING COMPLICATIONS WERE OBSERVED POST OP: PAIN IN HANDS/LEGS, SWELLING, NERVE DAMAGE. ON AN UNKNOWN DATE THE PATIENT PRESENTED WITH CERVICAL AND LUMBAR RADICULOPATHY, POLY AXONAL NEUROPATHY NERVE DAMAGE ON (B)(6) 2003 THE PATIENT UNDERWENT SPINAL FUSION SURGERY USING RHBMP-2/ACS. ON (B)(6) 2003 THE PATIENT UNDERWENT AN TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L4-5, L5-S1, AND EXPLORATION OF FUSION; ON (B)(6) 2005 THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE AT C5-6. ON AN UNKNOWN DATE IN 2006, THE PATIENT UNDERWENT A NECK FUSION SURGERY USING RHBMP-2/ACS. ON (B)(6) 2006 THE PATIENT UNDERWENT SURGERY FOR HARDWARE REMOVAL, EXPLORATION OF FUSION L4-5 AND S1 WITH RESECTION OF OSTEOPHYTIC SPURS AND ECTOPIC BONE AT L4-5 BILATERALLY. THERE WAS A LARGE ECTOPIC OSTEOPHYTIC BONE SPUR AT L4-5 ON THE LEFT AND A SMALLER ONE ON THE RIGHT. PRE/POST OP DX INCLUDED ECTOPIC BONE FORMATION ON (B)(6) 2006 THE PATIENT PRESENTED WITH CHRONIC PAIN ON (B)(6) 2007 THE PATIENT PRESENTED FOR OFFICE VISIT AND NO RETROGRADE EJACULATION WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354001 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other