BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830090 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02124
    Event Type
    Injury
    Date Received
    November 13, 2012
    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

    (B)(4).

    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 BACK SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT NOW HAS "SERIOUS PAIN, MENTAL ANGUISH, AND THE FEAR OF HAVING ANOTHER SURGERY."

    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 AN UNKNOWN DATE PATIENT WENT FOR AN OFFICE DUE TO LOWER BACK PAIN RADIATING DOWN THE RIGHT SIDE OF HER BODY AND NUMBNESS IN RIGHT HAND AND FOOT. ON (B)(6) 2010 THE PATIENT UNDERWENT A L4-5 AND L5-S1 FUSION USING RHBMP-2. POST-OP, THE PATIENT WAS TAKEN TO EMERGENCY ROOM DUE TO SWELLING IN HER FEET, LEG AND HANDS. PATIENT WAS ADMITTED INTO THE ICU WHERE THE PATIENT WAS DIAGNOSED FOR TWO CUTS IN RECTUM. ON AN UNKNOWN DATE PATIENT COMPLAINED OF NEW PAIN IN HER BUTTOCKS, LEFT SIDED PAIN ALL THE WAY DOWN TO HER KNEES; PATIENT CONTINUED TO HAVE LOWER BACK PAIN, AFTER SURGERY CONSTANT AND MORE INTENSE THAN BEFORE. PATIENT SOUGHT TREATMENT FROM ANOTHER DOCTOR FOR PAIN MANAGEMENT. REPORTEDLY TWO MONTHS STATUS POST THE SURGERY THE COULD NOT MOVE FROM THE WAIST DOWN. DURING THESE TWO MONTHS PATIENT HAD TO HAVE ASSISTANCE WITH PREPARING MEALS, BATHING AND ALL HOUSEHOLD CHORES. PATIENT ALSO HAS AN INCREASED FEAR OF CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110915AAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R