BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3283558 · Received August 12, 2013

    Report

    Report Number
    1030489-2013-03499
    Event Type
    Injury
    Date Received
    August 12, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    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

    CONCOMITANT PRODUCTS: USA PEEK INTERBODY CAGE, USA POLYAXIAL SCREWS, ALLOGRAFT, AUTOGRAFT (IMPLANT ). (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING STUDY FILMS OR PATIENT MEDICAL RECORDS 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/USED 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 THE PATIENT PRESENTED TO SPINAL SURGERY WITH GRADE 1 SPONDYLOLISTHESIS L3-4, PROBABLE SPONDYLITIC SPONDYLOLISTHESIS, FORAMINAL STENOSIS AND SEGMENTAL INSTABILITY. THE SURGERY CONSISTED OF: 1-GILL PROCEDURE L3 WITH BILATERAL DECOMPRESSION LATERAL RECESS 2-BILATERAL FACETECTOMY WITH FORAMINOTOMIES 3-TRANSFORAMINAL INTERBODY FUSION L3-4 ON THE LEFT 4-INSERTION OF SPINAL USA 12 MM PEEK INTERBODY CAGE 5-INSERTION OF SPINAL USA POLYAXIAL SCREWS 7.5 MM X 45 MM AT L3 AND L4 BILATERALLY 6-POSTERIOR LATERAL FUSION AT L3-4 USING RHBMP-2/ACS, CORTICAL AND CANCELLOUS AUTOGRAFT LOCAL AND AUGMENTATION WITH CANCELLOUS ALLOGRAFT 7-INTERBODY FUSION USING RHBMP-2/ACS AND CORTICAL AND CANCELLOUS AUTOGRAFT ON (B)(6) 2011; THE PATIENT UNDERWENT LEFT FRONTAL CRANIOTOMY WITH RESECTION OF TUMOR. REPORTEDLY, THE PATIENT SUSTAINED UNSPECIFIED INJURIES AFTER USE OF RHBMP-2/ACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385847 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110915AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other