BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BONE MORPHOGENETIC PROTEIN

    MDR report key: 2052210 · Received April 12, 2011

    Report

    Report Number
    1030489-2011-00406
    Event Type
    Injury
    Date Received
    April 12, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: WILLIAMS, BRIAN J., ET AL. DOES BMP INCREASE THE INCIDENCE OF PERIOPERATIVE COMPLICATIONS IN SPINAL FUSION? A COMPARISON OF 55,862 CASES OF SPINAL FUSION WITH AND WITHOUT BMP. SPINE 2011; (10.1097/BRS.0B013E318216D825). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE PRODUCTS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    THE PATIENTS' AVERAGE AGE WAS (B)(6) YEARS. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED FROM A RETROSPECTIVE ANALYSIS OF A MULTI-INSTITUTIONAL, MULTI-SURGEON DATABASE. THE FUSION CASES WERE PERFORMED FROM 2004 TO 2007 USING BMP. A VARIETY OF FUSION METHODS WERE USED (ANTERIOR CERVICAL, ANTERIOR/POSTERIOR, ANTERIOR THORALUMBAR, INTERLAMINAR FACET, POSTEROLATERAL, PLIF AND TILF). THE USE OF TWO DIFFERENT BONE MORPHOGENETIC PROTEINS (BMP) WAS NOTED IN THE LITERATURE ARTICLE (BMP-2 AND BMP-7); HOWEVER THE SUSPECT BMP WAS NOT IDENTIFIED WITH A PARTICULAR PATIENT COMPLICATION. SPECIFIC COMPLICATIONS WERE COLLECTED IN THE DATABASE WITH A FOCUS ON THE INTRA-OPERATIVE AND IMMEDIATE POST-OPERATIVE PERIODS. IT WAS REPORTED THAT 43 DELAYED NEUROLOGICAL DEFICITS OCCURRED MORE THAN 24 HOURS AFTER SURGERY WITH BMP. OVERALL THE DEFICITS IMPROVED, WITH A PARTIAL OR COMPLETE RECOVERY IN MOST CASES. THE NEUROLOGICAL DEFICITS WERE NOT ASSOCIATED WITH THE USE OF BMP. NEUROLOGICAL DEFICITS NOTED IN THE ARTICLE INCLUDED NERVE ROOT DEFICIT, CAUDA EQUINE SYNDROME, INCOMPLETE CORD DEFICITIS AND COMPLETE CORD DEFICITS.

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED FROM A RETROSPECTIVE ANALYSIS OF A MULTI-INSTITUTIONAL, MULTI-SURGEON DATABASE. THE FUSION CASES WERE PERFORMED FROM 2004 TO 2007 USING BMP. A VARIETY OF FUSION METHODS WERE USED (ANTERIOR CERVICAL, ANTERIOR/POSTERIOR, ANTERIOR THORALUMBAR, INTERLAMINAR FACET, POSTEROLATERAL, PLIF AND TILF). THE USE OF TWO DIFFERENT BONE MORPHOGENETIC PROTEINS (BMP) WAS NOTED IN THE LITERATURE ARTICLE (BMP-2 AND BMP-7); HOWEVER THE SUSPECT BMP WAS NOT IDENTIFIED WITH A PARTICULAR PATIENT COMPLICATION. BMP WAS USED IN 11,933 SPINAL FUSION CASES. THE PATIENTS' AVERAGE AGE WAS (B)(6) YEARS, INCLUDING PEDIATRICS. THE PATIENTS UNDERWENT SPINAL FUSION FOR A VARIETY OF REASONS (DEGENERATIVE SPINAL DISORDER, KYPHOSIS, SCOLIOSIS AND SPONDYLOLISTHESIS). IT WAS REPORTED THAT 43 DELAYED NEUROLOGICAL DEFICITS OCCURRED MORE THAN 24 HOURS AFTER SURGERY WITH BMP. OVERALL THE DEFICITS IMPROVED, WITH A PARTIAL OR COMPLETE RECOVERY IN MOST CASES. THE NEUROLOGICAL DEFICITS WERE NOT ASSOCIATED WITH THE USE OF BMP. NEUROLOGICAL DEFICITS NOTED IN THE ARTICLE INCLUDED NERVE ROOT DEFICIT, CAUDA EQUINE SYNDROME, INCOMPLETE CORD DEFICITIS AND COMPLETE CORD DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BONE MORPHOGENETIC PROTEIN FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR