BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2936044 · Received January 30, 2013

    Report

    Report Number
    1030489-2013-00315
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    February 15, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 USED 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 UNDERWENT UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "SIGNIFICANT PAIN AND REQUIRES [PATIENT] TO SEE A DOCTOR FREQUENTLY AFTER THE SURGERY AND HAS [PATIENT] CONSTANTLY WORRIED ABOUT WHETHER THINGS WILL GET WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FORAMINOTOMY WITH INTERBODY FUSION SURGERY AT L5-S1 IN WHICH RHBMP-2/ACS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41795 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110703AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention