BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3073095 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01249
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT "MEDICALLY UNNECESSARY, EXPERIMENTAL" SPINE SURGERIES WHERE CERVICAL AND THORACIC RODS, SCREWS, CAGES AND RHBMP-2/ACS WERE IMPLANTED. THE PATIENT HAS SUSTAINED INJURY WITHIN THE PAST FOUR YEARS. THE PATIENT HAS ALLEGEDLY UNDERGONE RELATED FOLLOW UP CARE, PHYSICAL THERAPY, PRESCRIPTIONS, INJECTIONS, AND IMAGE STUDIES.

    Description of Event or Problem · 1

    IN 2010, THE PATIENT HAD CHRONIC BACK PAIN ASSOCIATED WITH YEARS OF DANCING. SHE WAS DIAGNOSED WITH KYPHOTIC DEFORMITY OF THE THORACIC SPINE, THORACIC DISC HERNIATION, AND THORACIC SPINAL STENOSIS. ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY. THE SURGERY INVOLVED VIDEO-ASSISTED THORACOSCOPIC ANTERIOR DISECTOMY FROM T5-T6 TO T11-T12; ANTERIOR INTERBODY FUSION FROM T5-T6 TO T11-T12; PLACEMENT OF ANTERIOR INTERBODY CAGE FROM T5-T6 TO T11-T12; POSTERIOR SPINAL INSTRUMENTATION FROM T3 TO L2; AND POSTERIOR SPINAL FUSION USING AUTO AND ALLOGRAFT FROM T3 TO L2. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. THE PAIN WORSENED AFTER THE SURGERY. THE PATIENT CONTINUED TO HAVE SEVERE BACK PAIN AND TRIED MULTIPLE FORMS OF PHYSICAL THERAPY OVER THE NEXT SEVERAL MONTHS. ON (B)(6) 2012, THE PATIENT UNDERWENT SECOND SURGERY. THE SURGERY INVOLVED DIRECT LATERAL LUMBAR INTERBODY DISECTOMY FROM L3-L4; DIRECT LATERAL INTERBODY DISECTOMY FROM L4-L5; DIRECT LATERAL INTERBODY FUSION USING AUTO AND ALLOGRAFT FROM L3-L4 AND DIRECT LUMBER INTERBODY FUSION FROM L4-L5; PLACEMENT OF DIRECT LATERAL INTERBODY CAGE PEDICLE FROM L3-L4; PLACEMENT OF DIRECT LATERAL INTERBODY CAGE AT L4-L5; POSTERIOR SPINAL INSTRUMENTATION OF L3, L4, AND L5; POSTERIOR SPINAL FUSION FROM L2-L3, L3-L4, AND L4-L5 USING AUTO AND ALLOGRAFT; EXTENSION OF FUSION FROM L2-L5; LUMBAR LAMINECTOMY FROM L4-L5; AND LUMBAR FORAMINOTOMY FROM L4-L5, RIGHT SIDE. THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS. POST SECOND SURGERY, THE PATIENT CONTINUED TO EXPERIENCE PAIN IN HER BACK, HIPS, AND LEGS, WHICH CAUSED HER TO FALL DOWN STAIRS FOUR TIMES. THE SURGEON RECOMMENDED A DRAIN BE INSERTED INTO THE PATIENT TO DRAIN A POCKET OF FLUID THAT DEVELOPED ON HER SPINE, TO ALLEVIATE THE PAIN. THE DRAIN DID NOT ALLEVIATE PATIENT'S PAIN, AND SHE CONTINUED TO SUFFER SEVERE PAIN IN HER BACK, HIPS, AND LEGS. CURRENTLY, THE PATIENT SUFFERS FROM SEVERE BACK PAIN, NECK PAIN, HIP PAIN, LEG PAIN, HEADACHES, AND HAS MISSED LARGE AMOUNTS OF WORK DUE TO PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174634 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 Required Intervention