BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2884612 · Received December 23, 2012

    Report

    Report Number
    1030489-2012-02932
    Event Type
    Injury
    Date Received
    December 23, 2012
    Report Date
    May 23, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    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. 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 (B)(6), 2007 THE PATIENT UNDERWENT A C3-C7 ANTERIOR CERVICAL DISKECTOMY AND ARTHRODESIS. IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT A C3-C7 POSTERIOR CERVICAL FUSION. IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A DECOMPRESSION OF L4-L5 AND L5-S1, A TRANSFORAMINAL LUMBAR INTERBODY F USION L4-L5 AND L5-S1, THE PLACEMENT OF INTERBODY CAGES, POSTERIOR INSTRUMENTATION L4-L5 AND AND L5-S1, AND THE GRAFTING WITH CANCELLOUS ALLOGRAFT SUPPLEMENTED WITH BMP. IT WAS REPORTED THAT THE PATIENT NOW SUFFERS FROM CHRONIC PAIN SYNDROME, BACK PAIN, NECK PAIN, ANXIETY, AND NARCOTIC DEPENDENCE.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAS EXPERIENCED ECTOPIC BONE GROWTH, CHRONIC PAIN SYNDROME, BACK PAIN, NECK PAIN, ANXIETY, AND NARCOTIC DEPENDENCE FROM PRESCRIBED PAINKILLERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2008, THE PATIENT PRESENTED WITH POST OP FULL LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION . THE PATIENT HAD PSEUDARTHROSIS AND BROKE A SCREW. PER OP NOTES, "... SUBPERIOSTEAL DISSECTION WAS CARRIED OUT AT C3, C4, C5, C6, AND C7 WITH BOVIE ELECTROCAUTERY .. THE STARTER HOLES WERE DRILLED WITH A MIDAS REX AND THE DRILL GUIDE WAS USED TO PLACE SCREW HOLES AT C3, C4, CS, C6, AND C7 BILATERALLY. THE DEPTH GAUGE WAS USED TO GAUGE. SCREWS WERE PLACED. .. THE LAMINA AND SPINOUS PROCESS WAS DECORTICATED. FACETS WERE PACKED WITH BMP-SOAKED SPONGES AND THEN GRAFT PUTTY ON TOP OF THIS. RODS WERE PLACED. LOCKING SCREWS WERE PLACED AND FINALLY TIGHTENED. BMP-SOAKED SPONGE BURRITOS WITH GRAFT PUTTY WERE PLACED IN THE LATERAL GUTTERS AND IN BETWEEN THE SPINOUS PROCESSES. .. ."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION ACDF SURGERY USING INSTRUMENTATION AND RHBMP-2/ACS TO TREAT PSEUDOARTHROSIS AND A BROKEN SCREW. REPORTEDLY, THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS.

    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