BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1961973 · Received January 15, 2011

    Report

    Report Number
    1030489-2011-00051
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    September 29, 2010
    Report Date
    December 18, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: STACHNIAK, JB, ET AL. "ANALYSIS OF PREVERTEBRAL SOFT-TISSUE SWELLING AND DYSPHAGIA IN MULTILEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 IN PATIENTS AT RISK FOR PSEUDARTHROSIS." J NEUROSURGERY: SPINE DEC 2010. DOI: 10.3171/2010.9.SPINE09828. PEEK SPACERS AND TITANIUM PLATES - THERAPY DATES UNK. (B)(4). A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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.

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED IN RETROSPECTIVE STUDY OF 30 PATIENTS WHO UNDERWENT MULTILEVEL ANTERIOR CERVICAL DISCECTOMIES AND FUSIONS (ACDFS) USING POLYETHERETHERKETONE (PEEK) SPACERS WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2) IMPREGNATED TYPE I COLLAGEN SPONGE AND TITANIUM PLATES BETWEEN (B)(6) 2006 AND (B)(6) 2008. ALL PATIENTS RECEIVED BETWEEN 0.4ML (OR 0.6MG) OF RHBMP-2 PER LEVEL. FUSION AND SOFT TISSUE SWELLING WAS EVALUATED POST-OPERATIVELY. EACH PATIENT UNDERWENT CERVICAL SPINE RADIOGRAPHS AND CT SCAN POST-OP. TWENTY EIGHT PATIENTS EXPERIENCED ARM PAIN POST OP DAY ONE. THERE WAS PROGRESSIVE IMPROVEMENT OVER TIME. AT SIX MONTH FOLLOW-UP, TWENTY PATIENTS HAD ARM PAIN.

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED IN RETROSPECTIVE STUDY OF 30 PATIENTS WHO UNDERWENT MULTILEVEL ANTERIOR CERVICAL DISCECTOMIES AND FUSIONS (ACDFS) USING POLYETHERETHERKETONE (PEEK) SPACERS WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2) IMPREGNATED TYPE I COLLAGEN SPONGE AND TITANIUM PLATES BETWEEN (B)(6) 2006 AND (B)(6) 2008. ALL PATIENTS RECEIVED BETWEEN 0.4ML (OR 0.6MG) OF RHBMP-2 PER LEVEL. FUSION AND SOFT TISSUE SWELLING WAS EVALUATED POST-OPERATIVELY. EACH PATIENT UNDERWENT CERVICAL SPINE RADIOGRAPHS AND CT SCAN POST-OP. TWENTY EIGHT PATIENTS EXPERIENCED ARM PAIN POST OP DAY ONE. THERE WAS PROGRESSIVE IMPROVEMENT OVER TIME. AT SIX FOLLOW-UP TWENTY PATIENTS HAD ARM PAIN.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1