BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3050926 · Received April 10, 2013

    Report

    Report Number
    1030489-2013-00980
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    December 1, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 , THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH LEFT CERVICAL RADICULOPATHY. C5-6 AND C6-7 SEVERE DISK DEGENERATION WITH SEVERE SPINAL STENOSISCENTRALLY AND AT THE NEURAL FORAMINA. C4-5 LEFT FACET ARTHROSIS WITH A HYPERTROPHY WITH GRADE 1 ANTERIOR SPONDYLOLISTHESIS. C3-4 RIGHT FACET SEVERE ARTHROSIS AND HYPERTROPHY AND UNDERWENT THE FOLLOWING PROCEDURES: STAGE I ANTERIOR CERVICAL DISKECTOMY AND FUSION OF C3-4, C4-5, C5-6, C6-7. CORPECTOMY OF C6 FOR THE DECOMPRESSION OF C5-6 AND C6-7. PLACEMENT OF SYNTHETIC CAGES AT C3-4, C4-5, AND SPANNING FROM C5 TO C7. PLACEMENT OF TITANIUM PLATES SPANNING FROM C3 TO C7. USE OF LOCAL AUTOGRAFT CORPECTOMY BONE. USE OF ALLOGRAFT BONE. USE OF FLUOROSCOPIC C-ARM. STAGE II POSTERIOR SPINAL FUSION AT C3-4, C4-5, C5-6, AND C6-7. PLACEMENT OF NUVASIVE TITANIUM INSTRUMENTATION SPANNING FROM C3 TO C7. USE OF AUTOGRAFT BONE. USE OF BONE MORPHOGENETIC PROTEIN. PLACEMENT AND REMOVAL OF MAYFIELD HEAD HOLDER TONGS. USE OF FL UOROSCOPIC C-ARM GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149756 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other