BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 6649406 · Received June 19, 2017

    Report

    Report Number
    1030489-2017-01562
    Event Type
    Injury
    Date Received
    June 19, 2017
    Report Date
    May 22, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    UDI-DI
    00613994239518
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 ON (B)(6) 2008, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS AND STRUCTURAL INSTABILITY C3-4 CERVICAL SPINE. HERNIATED NUCLEUS PULPOSUS, SPINAL STENOSIS, DEGENERATIVE DISC AND JOINT DISEASE C3-4. SPINAL CORD COMPRESSION C3-4/MYELOPATHY AND UNDERWENT FOLLOWING PROCEDURES: ANTERIOR NEURAL DECOMPRESSION C3-4. ANTERIOR DISCECTOMY AND FUSION C3-4. ANTERIOR CAGE FIXATION C3-4. ANTERIOR PLATE FIXATION C3-4. INTRA-OPERATIVE BI-PLANE FLUOROSCOPY. AS PER OP-NOTES, ¿FLOSEAL AND GELFOAM PLACED OVER THE ANTERIOR CORD, AND THEN A 7.0 MM PEEK IMPLANT FILLED WITH CANCELLOUS AUTOLOGOUS BONE AND BONE MORPHOGENIC PROTEIN WAS PLACED INTO INTRADISCAL SPACE AT C3-4. THEN A PLATE WAS PLACED ON THE ANTERIOR BODY OF C3 AND C4 WITH TWO UNICORTICAL CANCELLOUS SCREWS PROXIMALLY AND DISTALLY AND LOCKED SECURELY.¿ POST OPERATIVELY PATIENT ALLEGES UNSPECIFIED INJURY DUE TO THE USE OF RHBMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430680 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110715AAB 00613994239518

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other