BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3131742 · Received May 29, 2013

    Report

    Report Number
    1030489-2013-01915
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    October 4, 2018
    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)(6). (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

    DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. .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 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 THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: SPONDYLOTIC LUMBAR SPINAL STENOSIS. MULTI-ROOT LUMBAR RADICULOPATHY. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: LUMBAR LAMINECTOMY WITH SPINAL CANAL, LATERAL RECESS, AND FORAMINAL DECOMPRESSIONS, L2, L3 , L4, AND L5; POSTEROLATERAL ARTHRODESIS USING THE CONSTRUCT OF AUTOGRAFT, ALLOGRAFT WITH ACTIVATED GLASS (ORIGEN) , AND RHBMP-2. AS PER OPERATIVE NOTES,¿ THE PATIENT UNDERWENT AN URGENT CERVICAL DECOMPRESSION BY ANTERIOR CERVICAL MICROSCOPIC DISKECTOMY FOLLOWED BY AN INTERBODY GRAFT CONSTRUCT OF PEEK, AUTOGRAFT AND TRINITY ALLOGRAFT. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236586 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110804AAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other