BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3171722 · Received June 16, 2013

    Report

    Report Number
    1030489-2013-02323
    Event Type
    Injury
    Date Received
    June 16, 2013
    Report Date
    December 15, 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 THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS, L5-S1. MECHANICAL LOW BACK PAIN. L5 RADICULOPATHIES AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR LUMBAR INTERBODY FUSION, L5-S1 WITH PLACEMENT IF INTERVERTEBRAL BIOMECHANICAL SPACER FILLED WITH BMP. ANTERIOR LUMBAR DISCECTOMY, L5-S1. POSTERIOR SEXTANT INSTRUMENTATION FOR SEGMENTAL FIXATION L 5-S1. OPEN REDUCTION OF SPONDYLOLISTHESIS/FRACTURE. INTRAOPERATIVE IMAGE-GUIDED SURGICAL NAVIGATION UTILIZING THE O RING IN WHICH RHBMP2/ACS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272724 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other