BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830238 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02154
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    December 29, 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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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)

    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

    REPORTEDLY, THE PATIENT DEVELOPED "SERIOUS PROBLEMS, INCLUDING PAIN, NERVE INJURIES, MENTAL ANGUISH," AND IS "WORRIED THAT THINGS WILL KEEP GETTING WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2010: THE PATIENT UNDERWENT A REVISION SURGERY AT WHICH HARDWARE WAS REMOVED AT L5-S1. A FUSION WAS ALSO PERFORMED AT L4-L5 VIA PLIF. BMP AND A PEEK CAGE WERE USED ONCE AGAIN. ON AN UNKNOWN DATE, PATIENT HAD BLADDER AND BOWEL INCONTINENCE AND ALSO HAD PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT UNDERWENT SPINE FUSION SURGERY ON THE LUMBAR REGION OF HER SPINE FROM VERTEBRAE L4 TO L5 USING RHBMP-2 FROM A POSTERIOR APPROACH. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E., IN THE DISC SPACE). DESPITE REVISION SURGERY, PATIENT CONTINUED TO EXPERIENCE CHRONIC LOWER BACK PAIN, WITH PAIN RADIATING INTO HER HIPS AND LEGS, NUMBNESS AND TINGLING IN HER LEFT LEG, SWELLING IN HER LEFT GROIN AND THIGH, AND MUSCLE SPASMS. PATIENT EXPERIENCED DIFFICULTY IN SITTING FOR EXTENDED PERIODS AND CONSTANTLY LIED DOWN. SHE HAD DIFFICULTY WALKING, WORE A BACK BRACE DAILY, AND FELL OFTEN. SHE REQUIRED USE OF A WALKER IN ORDER TO STAND UP, AND A CANE TO ASSIST IN AMBULATION. PATIENT ALSO SUFFERED FROM BLADDER AND BOWEL ISSUES. THESE SERIOUS INJURIES PREVENTED PATIENT FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE THAT SHE ENJOYED PRE-OPERATIVELY, AND SHE OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES.

    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.

    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 M110806AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other