BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3894984 · Received June 25, 2014

    Report

    Report Number
    1030489-2014-02905
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    March 23, 2016
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION FROM L3 TO L4 USING RHBMP-2/ACS ON (B)(6) 2007, WITH THE RHBMP-2 BEING PLACED IN THE DISC SPACE. SOMETIME POSTOP, THE PATIENT REPORTEDLY EXPERIENCED SEVERE LOW BACK PAIN, PAIN RADIATING INTO HER BUTTOCKS, AND PAIN, NUMBNESS AND TINGLING IN HER LOWER EXTREMITIES AND SPASMS. A LUMBAR MRI SCAN DATED (B)(6) 2010 SHOWED BONY OVERGROWTH CAUSING COMPRESSION ON THE SPINE. ON (B)(6) 2010, THE PATIENT UNDERWENT A REVISION SURGERY TO RELIEVE STENOSIS AND REMOVE OVERGROWN BONE. SHE REQUIRES THE ASSISTANCE OF A CANE WHEN AMBULATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2000, THE PATIENT UNDERWENT CERVICAL SPINE EXAMINATION. ON (B)(6) 2001, THE PATIENT PRESENTED WITH COMPLAINT OF NECK PAIN AND UNDERWENT NEUROCONSULTATION. IMPRESSION: CERVICAL DISK DISEASE. BILATERAL CARPAL TUNNEL SYNDROME. INTERNAL DERANGEMENT OF THE RIGHT SHOULDER. ON (B)(6) 2001, THE PATIENT PRESENTED WITH COMPLAINT IN NECK AND NUMBNESS OF HER HANDS. ON (B)(6) 2001, THE PATIENT PRESENTED FOR FOLLOW UP VISIT. ON (B)(6) 2001, THE PATIENT PRESENTED FOR ELECTROMYOGRAPHY. THE STUDIES SHOWED FAIRLY MINOR RADICULAR FINDINGS. SHE DID HAVE PROMINENT CARPAL TUNNEL SYNDROME. ON (B)(6) 2004, THE PATIENT PRESENTED STATUS POST ANTERIOR CERVICAL PARTIAL VERTEBRECTOMY, WITH FUSION PLATING AT THE C3-4 AND C6-7 LEVELS. ON (B)(6) 2004, THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP. THE PATIENT COMPLAINT OF SEVERE NECK PAIN. ON (B)(6) 2007, THE PATIENT PRESENTED WITH COMPLAINT OF HER LEFT ELBOW PAIN. ON (B)(6) 2007, THE PATIENT PRESENTED FOR NEUROSURGICAL EVALUATION AND HAD MRI REVIEW WHICH WAS PERFORMED ON (B)(6) 2006. IMPRESSION: LOW BACK PAIN RADIATING TO THE RIGHT LEG MORE THAN THE LEFT. EVIDENCE OF MODERATELY LARGE DISC BULGE AT L3-4 AND L4-5 AND A MILD DISC BULGE AT L5-S1. SHE HAD MILD L4 MOTOR RADICULOPATHY. ON (B)(6) 2007, THE PATIENT WAS ADMITTED WITH LEFT L3-4 DYSKINESIA AND DISC DEGENERATION CAUSING HER SEVERE LEFT LEG PAIN. THE PATIENT UNDERWENT LEFT L3-4 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH INSTRUMENTATION. IMPRESSION: THE PATIENT HAD BACK AND LEG PAIN DUE TO MAINLY DEGENERATED AND HERNIATED DISK AT L3-4. ON (B)(6) 2007, THE PATIENT GOT DISCHARGED FROM FACILITY. ON (B)(6) 2007, THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2007, THE PATIENT HAD X-RAY OF LUMBAR SPINE. IMPRESSION; PREVIOUS SURGERY AT THE L3-4 DISC SPACE APPEARED STABLE WITH NO SUB LUXATION DEMONSTRATED BETWEEN FLEXION AND EXTENSION VIEWS. ON (B)(6) 2007, THE PATIENT PRESENTED WITH ELECTROMYOGRAPHY REPORT. IMPRESSION: S1 RADICULITIS ON THE LEFT. L5 RADICULITIS ON THE RIGHT. PERIPHERAL NEUROPATHY. THE PATIENT UNDERWENT MRI OF LEFT HIP. THE PATIENT UNDERWENT CT OF LUMBAR SPINE. IMPRESSION: MILD COMPRESSION FRACTURE WAS SEEN AT POSTERIOR SUPERIOR ENDPLATE OF L5. ON (B)(6) 2007, THE PATIENT PRESENTED WITH COMPLAINT OF LEFT KNEE PAIN. IMPRESSION: HER KNEE JOINT PAIN AND BACK AND HIP PAIN SEEMED TO BE LIMITING HER ACTIVITY. ON (B)(6) 2007, THE PATIENT PRESENTED WITH COMPLAINT OF LEFT HIP PAIN RADIATING DOWN HER LEFT LEG. ON (B)(6) 2007, THE PATIENT PRESENTED WITH COMPLAINT OF INTRACTABLE BACK PAIN THAT RADIATED INTO HER HIPS AND DOWN HER LEGS. ASSESSMENT: LUMBAR DISC DISEASE WITH L5-S1 RADICULITIS. OSTEOPOROSIS WITH COMPRESSION FRACTURE. PERIPHERAL NEUROPATHY. ON (B)(6) 2007, THE PATIENT PRESENTED FOR VISIT. IMPRESSION: DERMATITIS. ON (B)(6) 2008, THE PATIENT PRESENTED FOR FOLLOW UP. IMPRESSION: THE BACK PAIN IS LIKELY DUE TO L5-S1 DISC DEGENERATION. ON (B)(6) 2008, THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2008, THE PATIENT PRESENTED FOR FOLLOW UP. IMPRESSION: ARTHROPATHY OF THE KNEES. PERIPHERAL NEUROPATHY. OSTEOPOROSIS. ON (B)(6) 2008, THE PATIENT UNDERWENT MRI OF RIGHT KNEE. IMPRESSION: MILD CHONDROMALACIA PATELLA. FLUID COLLECTION IS SEEN BETWEEN THE ILIOTIBIAL BAND AND LATERAL FEMORAL EPICONDYLE. THIS SUGGEST ILIOTIBIAL BAND SYNDROME. ON (B)(6) 2008, THE PATIENT HAD MRI OF LEFT KNEE. IMPRESSION: MILD CHONDROMALACIA PATELLA. FLUID COLLECTION IS SEEN BETWEEN THE ILIOTIBIAL BAND AND LATERAL FEMORAL EPICONDYLE. THIS SUGGEST ILIOTIBIAL BAND SYNDROME. ON (B)(6) 2008, THE PATIENT PRESENTED FOR FOLLOW UP OF HER BILATERAL KNEE PAIN. ON (B)(6) 2008, THE PATIENT PRESENTED FOR FOLLOW UP ON (B)(6) 2008, THE PATIENT PRESENTED WITH ELECTROMYOGRAPHY REPORT. IMPRESSION: CHRONIC S1 RADICULITIS ON THE RIGHT. ON (B)(6) 2008, THE PATIENT HAD GONE MRI LUMBAR SPINE. IMPRESSION; MULTILEVEL DEGENERATIVE DISC DISEASE ELSEWHERE IN THE LUMBAR SPINE HAS NOT CHANGED SIGNIFICANTLY. ON (B)(6) 2008, THE PATIENT HAD A FOLLOW UP VISIT AND REQUESTED FOR MEDICINE REFILL. IMPRESSION: OSTEOPOROSIS. ON (B)(6) 2008, THE PATIENT RETURNED FOR FOLLOW UP OF HER BACK PAIN. ON (B)(6) 2008, THE PATIENT UNDERWENT CT OF LUMBAR SPINE WHICH INDICATED SOLID FUSION AT C3-4 WITH LEFT PEDICLE SCREW HARDWARE. ON (B)(6) 2009, THE PATIENT PRESENTED FOR FOLLOW UP FOR DEGENERATIVE DISC DISEASE AT L5-S1 AND HERNIATED DISCS AT L3-4 AND L4-5. CT OF LUMBAR WAS REVIEWED. IMPRESSION: THE PATIENT HAD HERNIATED DISCS AT L3-4, L4-5 & L5-S1 AND DEGENERATIVE DISC DISEASE AT L5-S1. ON (B)(6) 2009, THE PATIENT UNDERWENT CHEST X-RAY. IMPRESSION: MILD CHRONIC ELEVATION OF THE RIGHT HEMIDIAPHRAGM WITH BORDERLINE CARDIAC SIZE WITHOUT EVIDENCE OF ACUTE PULMONARY INFILTRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370810 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