BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2861812 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02670
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    October 27, 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) 2004: THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOSIS WITH DEGENERATIVE LISTHESIS, C4-5, AND SPONDYLOSIS WITH FORAMINAL STENOSIS C4-5 AND C5-6 AND UNDERWENT THE FOLLOWING PROCEDURE: ANTERIOR CERVICAL DISCECTOMY WITH BILATERAL FORAMINOTOMY FOR NERVE ROOT DECOMPRESSION WITH ANTERIOR INTERBODY FUSION UTILIZING OSTEON CAGES WITH RHBMP-2/ACS ALLOGRAFT AT C4-5, C5-6, AND C6-7, MICROSURGICAL TECHNIQUE, WITH IMPLANTATION OF CERVICAL PLATE AT C4 THROUGH C7 (FPSOL). THE PATIENT UNDERWENT IMAGING STUDIES PRIOR TO SURGERY WHICH REVEALED ADVANCED CERVICAL SPONDYLOSIS WITH DISK SPACE COLLAPSE AND FORAMINAL STENOSIS, AS WELL AS A GRADE I DEGENERATIVE LISTHESIS AT C4-5 WITH DISK SPACE COLLAPSE AND FORAMINAL STENOSIS AT C5-6 AND C6-7 WITH REVERSAL OF THE CERVICAL CURVATURE.

    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 USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other