BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3202536 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02916
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    September 5, 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) 2011: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4-L5 AND L5-S1 DEGENERATIVE DISCS: A) CENTRAL HERNIATED NUCLEUS PULPOSUS. B) FORAMINAL STENOSIS AND UNDERWENT THE FOLLOWING PROCEDURE: L4-L5 AND L5-S1 ANTERIOR LUMBAR INTERBODY FUSIONS WITH COMPLETE DECOMPRESSIVE DISCECTOMIES X2, PEEK SPACERS X2, BONE MORPHOGENIC PROTEIN AND 2 SEPARATE PLATES WITH SCREWS UNDER FLUOROSCOPIC CONTROL. AS PER OP-NOTES, ¿ONCE ADEQUATE DISCECTOMY WAS COMPLETE AND END PLATE SURFACES WERE PREPARED, THE SPACE WAS SIZED. IT WAS ELECTED TO PUT A LARGE FOOTPRINT 12-MM, 8-DEGREE SPACER IN; THE TRIAL GAVE GOOD FIT AND FILL. THE ACCOMPANYING RASP WAS EMPLOYED UNDER FLUOROSCOPIC CONTROL. BMP HAD BEEN PREPARED MORE THAN 20 MINUTES PRIOR TO IMPLANTATION FOR THE FIRST LEVEL. THE REAL PEEK SPACER WAS PACKED WITH BMP SPONGES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302820 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