BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2861684 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02664
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    October 17, 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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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.

    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

    REPORTEDLY, THE PATIENT DEVELOPED "SIGNIFICANT PAIN AND REQUIRED [PATIENT] TO SEE A DOCTOR FREQUENTLY AFTER SURGERY. [PATIENT] HAS BEEN IN PAIN EVER SINCE [PRODUCT] WAS INSTALLED IN LOWER BACK. [PATIENT] NOW HAS NERVE DAMAGE AND TAKES 1200 MG OF GABAPENTIN FOR PAIN, AND 4 30MG PILLS OF OXYCODONE AND 16 MG OF DILAUDID EVERY DAY. [PATIENT'S] RIGHT LEG FREEZES UP ON [PATIENT] WHEN [PATIENT] TRIES TO SIT DOWN ON THE TOILET; NOT ALL THE TIME, BUT A COUPLE TIMES IT WAS A MESS. GOT CRUSHED AT WORK; 8 POUNDS OF MATERIAL FELL ON PATIENT FROM 15 FEET IN THE AIR. (B)(6) IS RUNNING OUT SOON. [PATIENT] HAS NO INCOME AND STILL IN PAIN. [PATIENT] WAS IN PERFECT SHAPE WHEN [PATIENT] WENT TO WORK THAT DAY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2009: THE PATIENT UNDERWENT ANTERIOR AND POSTERIOR LUMBAR INTERBODY FUSION AT L5-S1 IN WHICH RH-BMP2/ACS WAS USED.

    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 M110707AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R