BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2032855 · Received March 29, 2011

    Report

    Report Number
    1030489-2011-00347
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: HAMILTON, DK, ET AL. SAFETY EFFICACY AND DOSING OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2) FOR POSTERIOR CERVICAL AND CERVICO-THORACIC INSTRUMENTED FUSION WITH A MINIMUM TWO YEAR FOLLOW UP. NEUROSURGERY 2011(10.1227/ (B)(4)) AUTOGRAFT/ALLOGRAFT INSTRUMENTATION (DETAILS NOT PROVIDED). (B)(4). MULTIPLE PRODUCTS 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. NEITHER THE DEVICE NOR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    PERI-OPERATIVE COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE LITERATURE ARTICLE OF PATIENTS THAT UNDERWENT POSTERIOR CERVICAL INSTRUMENTED FUSION FROM AUGUST 2003 TO MARCH 2008, INCLUDING OCCIPITO-CERVICAL, CERVICAL AND CERVICO-THORACIC FUSIONS, USING RECOMBINANT HUMAN MORPHONGENETIC PROTEIN (RHBMP-2). THE AVERAGE DOSE OF RHBMP-2 WAS 1.8 MG/LEVEL WITH A TOTAL OF 282 LEVELS TREATED (AVERAGE 5.3 LEVELS). NO CASES OF DYSPHAGIA OR NECK SWELLING REQUIRING TREATMENT WERE IDENTIFIED. AT LAST FOLLOW-UP, ALL PATIENTS HAD ACHIEVED FUSION. ONE PATIENT DEVELOPED A SUPERFICIAL WOUND INFECTION. NO FURTHER DETAILS WERE PROVIDED.

    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 00055 YR