BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4130143 · Received September 30, 2014

    Report

    Report Number
    1030489-2014-03772
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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) 2005 THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF: HERNIATED NUCLEUS PULPOSUS AT C5-6; MYELOPATHY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISKECTOMY AT C5-6; ARTHRODESIS AT C5-6 WITH PEEK CAGE AND AUTOGRAFT AND MORSELIZED ALLOGRAFT; FIXATION AT C5-6 WITH GLOBUS ANTERIOR PLATING SYSTEM. FINDINGS: LARGE CENTRAL DISK HERNIATION. PER OP NOTES, ONCE THE SURGEON WAS DONE WITH THE OVERALL DECOMPRESSION, ARTHRODESIS WAS PERFORMED. THE SURGEON TOOK A 7 LORDOTIC CURVE PEEK CAGE MIXED WITH AUTOGRAFT OBTAINED FROM THE END PLATES AND THE BMP AND MORSELIZED ALLOGRAFT MIXED IN. THE SURGEON THEN GENTLY TAPPED THIS INTO THE DISK SPACE. IT WAS COUNTERSUNK A FEW MM. THE SURGEON THEN TOOK A METAL PLATE AND SECURED IT TO C5 WITH 2 MEDICAL SCREWS AND IN C6 WITH 2 SCREWS. THE WOUND WAS THEN IRRIGATED WITH COPIOUS AMOUNTS OF ANTIBIOTIC. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN A STABLE CONDITION. NO PATIENT COMPLICATIONS WERE NOTED. ON 11/18/2011 THE PATIENT UNDERWENT CT OF LUMBAR MYELOGRAM WITH MULTI-REFORMATTED 3D IMAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607279 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 Other