BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2862457 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02716
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    March 18, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF IMAGING STUDIES FOUND AS FOLLOWS: (B)(4) 2011 CERVICAL MRI SAGITTAL FILMS T2 SHOWS SEVERE DDD WITH COLLAPSE OF DISC SPACES MOST SEVERE THROUGH C4-C6. DISC OSTEOPHYTE COMPLEX CREATES SEVERE CORD COMPRESSION AT C5/6. STENOSIS AT C4/5 CREATES CORD COMPRESSION WITH CORD SIGNAL CHANGE SUGGESTIVE OF EDEMA AND POSSIBLE CORE INJURY. THIS IS A PRESURGICAL STUDY. ON (B)(4) 2012, CT NECK WITH AND WITHOUT CONTRAST NEURAL ACCESS IS OBSCURED BY METAL ARTIFACT. CORPECTOMY HAS BEEN PERFORMED AT C5 WITH INTERBODY RECONSTRUCTION C4 TO C6 AND ANTERIOR PLATING C4 THROUGH C6. ALIGNMENT CANNOT BE VERIFIED BY THESE STUDIES. ON (B)(4) 2012, MRI CERVICAL SPINE MRI SHOWS EXCELLENT DECOMPRESSION OF CERVICAL STENOSIS BEHIND THE C5 CORPECTOMY. THERE APPEARS TO BE NO RESIDUAL EDEMA TO SUGGEST MOVEMENT OR FAILURE OF DEVICES. GLOBAL KYPHOSIS REMAINS THROUGH C4 TO C6 AREA. BORDERLINE STENOSIS APPEAR TO EXIST BEHIND INFERIOR C4 BODY. CORD AT THIS LEVEL APPEARS TO MEASURE ABOUT 8 MM IN AP DIAMETER. THE DEVICE WAS NOT 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

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

    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 67 YR Required Intervention