BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3902999 · Received June 30, 2014

    Report

    Report Number
    1030489-2014-02963
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    August 3, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 PATIENT PRESENTED WITH A LONG HISTORY OF NECK AND ARM PAIN UNRESPONSIVE TO CONSERVATIVE TREATMENT, C5-6 AND C6-7 DISC HERNIATION AND STENOSIS. THE PATIENT UNDERWENT C5-7 ACDF WITH ALLOGRAFT AND SYNTHES PLATE. ON (B)(6) 2008 PATIENT PRESENTED WITH L2 TO L4 DISC HERNIATION, DEGENERATION, AND DISCOGENIC PAIN. THE PATIENT UNDERWENT REMOVAL OF HARDWARE AND EXPLORATION OF FUSION L4-5, AND L2-L4 POSTERIOR SPINAL FUSION WITH TALON PEDICLE SCREW INSTRUMENTATION, ALLOGRAFT, RHBMP-2/ACS, AND LOCAL BONE. ON (B)(6) 2008, PATIENT PRESENTED FOR POST-OP FOLLOW UP. HIS POST-OP PAIN IS IMPROVING. X-RAYS SHOW THE HARDWARE INTACT AND THE FUSION IMPROPER ALIGNMENT. ON (B)(6) 2008 PATIENT PRESENTED FOR FOLLOW UP WITH COMPLAINTS OF ¿ODD FEELINGS AND SOUNDS IN HIS LOWER BACK.¿ X-RAYS SHOW NO CHANGES. ON (B)(6) 2008, PATIENT PRESENTED FOR FOLLOW UP. NOTED HIS SYMPTOMS ARE SLOWLY IMPROVING. X-RAYS SHOW THE HARDWARE TO BE STABLE, ¿THE FUSION IS PROGRESSING.¿ ON (B)(6) 2008, PATIENT PRESENTED FOR FOLLOW UP. ¿THE PAIN IS IMPROVING SLIGHTLY, ALTHOUGH HE STILL HAS SOME RESIDUAL BACK PAIN THAT DOES LIMIT HIS ABILITY¿. HE HAS DECREASED RANGE OF MOTION WITH SOME PAIN ON MOTION, BUT NO SPASM OF HIS BACK. NEUROLOGICALLY HE IS INTACT¿ X-RAYS SHOW THE HARDWARE INTACT AND THE FUSION PROGRESSING.¿ ON (B)(6) 2009, PATIENT PRESENTED FOR FOLLOW UP. ¿HE DOES HAVE DECREASED RANGE OF MOTION WITH PAIN ON MOTION OF THE NECK. HE HAS POSITIVE SPURLING SIGN.¿ PHYSICIAN¿S IMPRESSION: CERVICAL AND LUMBAR DISC HERNIATION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL EXTREMITY PAIN, LEFT GREATER THAN RIGHT. PER THE PHYSICIAN¿S NOTES, ¿HE EXPERIENCES NUMBNESS AND TINGLING IN BILATERAL EXTREMITIES FROM HIS LATERAL THIGHS DOWN TO THE ANTERIOR PORTION OF HIS SHIN AND INTO HIS FEET. HE ALSO COMPLAINS OF LOWER EXTREMITY WEAKNESS WITH EXERTION AND USE. HE OCCASIONALLY FALLS AND TRIPS OVER HIS FEET AS WELL.¿ A CT OF THE LUMBAR SPINE INDICATED ¿INTERVAL ANTERIOR INTERBODY FUSIONS WITH CARBON CAGES AT L2-3 AND L3-4 WITH SUCCESSFUL WIDENING OF THE DISC SPACES. ANTERIOR INTERBODY FUSION AT L4-5 UNCHANGED. THE TRANSPEDICULAR SCREWS AT L5 HAVE BEEN REMOVED THE NEW POSTERIOR FIXATION DEVICE INCORPORATES THE LEVEL OF L4-5.¿ ON (B)(6) 2012, THE PATIENT UNDERWENT ELECTRODIAGNOSTIC TESTING. CLINICAL IMPRESSION: ¿CHRONIC LOW BACK PAIN WITH CHRONIC LEFT L5 LUMBAR RADICULOPATHY.¿ ON (B)(6) 2013, PATIENT PRESENTED WITH COMPLAINTS OF LEFT GREATER THAN RIGHT LOW BACK PAIN AND LEFT-SIDED RADICULAR PAIN. PER THE PHYSICIAN¿S NOTES, ¿HE HAD AN MRI THAT SHOWED NO CENTRAL OR NEURAL FORAMINAL STENOSIS. HE ALSO HAD A CT SCAN THAT SHOWED THAT AS HIS MOST ROSTRAL PEDICLE SCREW THE ROD HAD COME OUT, WITH THE LOCKING CAP HANGING OUT IN HIS MUSCLE¿ HE HAS AN EMG THAT SHOWS AN OLD CHRONIC L5 LEFT RADICULOPATHY. OTHERWISE, NO EVIDENCE OF A RIGHT LUMBAR RADICULOPATHY OR POLY OR PERIPHERAL NEUROPATHY.¿ ON (B)(6) 2013, A CT OF THE ABDOMEN INDICATED ¿WITHIN SEGMENT 7 OF THE RIGHT HEPATIC LOBE, THERE IS A 4.2 X 3.0 CM LOBULATED LESION DEMONSTRATING PERIPHERAL NODULAR ENHANCEMENT ON PORTAL VENOUS PHASE IMAGING MOST SUGGESTIVE OF A BENIGN HEMANGIOMA.¿ ON (B)(6) 2013, MEDICAL RECORD NOTES ¿TEST RESULTS ¿ BENIGN RIGHT LOBE OF LIVER HEMANGIOMA¿ ON (B)(6) 2013, MEDICAL RECORDS NOTE THAT PATIENT WAS RECEIVING PRESCRIPTIONS FOR HYDROCODONE FROM TWO DIFFERENT PROVIDERS. ONE PROVIDER DECLINED TO REFILL THE PRESCRIPTION WHEN THEY BECAME AWARE OF THE SITUATION. ON (B)(6) 2013, PATIENT PRESENTED WITH WORSENING PAIN. DECOMPRESSIVE SURGERY WAS DISCUSSED. ON (B)(6) 2013, PATIENT UNDERWENT EXPLORATION OF FUSION AND REMOVAL OF LEFT L2 SCREW AND ROD CONNECTING LEFT L2 TO LEFT L3. ON (B)(6) 2013, PATIENT PRESENTED FOR SUTURE REMOVAL. ¿ALL SUTURES WERE REMOVED SUCCESSFULLY AND HIS INCISION APPEARS WELL HEALED.¿ ON (B)(6) 2013, PATIENT PRESENTED FOR POST-OP FOLLOW UP WITH COMPLAINTS OF CHRONIC LOW BACK PAIN. LEFT PARASPINAL MUSCLE PAIN HAS IMPROVED. ON (B)(6) 2014, PATIENT PRESENTED WITH ACUTE ABDOMINAL PAIN. ABDOMINAL RIGHT UPPER QUADRANT ULTRASOUND INDICATED ¿FATTY LIVER. OTHERWISE UNREMARKABLE RIGHT UPPER QUADRANT ULTRASOUND.¿ ON (B)(6) 2014, PATHOLOGY REPORT OF COLONOSCOPY AND STOMACH, ANTRAL BIOPSY FOUND ¿STOMACH, ANTRAL BIOPSY: MILD CHRONIC GASTRITIS WITH PATCHY LYMPHOID AGGREGATES, FOCAL INTESTINAL METAPLASIA, SPECIAL STAIN SHOWS NO HELICOBACTER LIKE ORGANISMS. ASCENDING COLON, POLYP BIOPSY: TUBULAR ADENOMA.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON : ON (B)(6) 2007, PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS : C5-C6 AND C6-C7 DISC HERNIATION AND STENOSIS. INTRAOPERATIVE X-RAY WAS USED TO CONFIRM THE LEVEL . ONCE THE DECOMPRESSION WAS COMPLETED AND THE ENDPLATES WERE DECORTICATED, 8-MM ALLOGRAFT SEGMENTS WERE FITTED INTO EACH DISC SPACE WITH GOOD FIT AND THEN A 32-MM PLATE WITH TWO SCREWS INTO CS, TWO INTO C6, AND TWO INTO C7 WAS PLACED IN THE DISC SPACE WITH GOOD FIT. (B)(6) 2008 , PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS : L2 TO L4 DISC HERNIATION, DEGENERATION, AND DISCOGENIC PAIN . HE UNDERWENT FOLLOWING PROCEDURE : L2 TO L4 POSTERIOR SPINAL FUSION WITH TALON PEDICLE SCREW INSTRUMENTATION, ALLOGRAFT, AND LOCAL BONE AND ALSO REMOVAL OF HARDWARE, EXPLORATION, AND FUSION AT L4-L5. INCISION WAS MADE THROUGH THE PREVIOUS INCISION AND THE SPINE WAS EXPOSED FROM L2 TO L5. THE PREVIOUS HARDWARE FROM L4 TO LS WAS DISSEMBLED AND REMOVED WITH THE SCREWDRIVERS AND THE FUSION WAS INSPECTED AND WAS FOUND TO BE QUITE SOLID. PEDICLE SCREWS WERE THEN PLACED INTO THE PEDICLES OF L2, L3, AND L4 BILATERALLY. INTRAOPERATIVE X-RAY AND EMG MONITORING SHOWED GOOD PLACEMENT OF THE SCREWS. THE SPINE WAS THEN DECORTICATED WITH A HIGH-SPEED BUR AT THE FACET JOINT AND TRANSVERSE PROCESSES. THEN ALLOGRAFT AND RHBMP2 WAS PLACED POSTEROLATERALLY. THE SCREWS WERE THEN CONNECTED BY RODS AND LOCKED AND TORQUED IN PLACE. NO POST OP COMPLICATION REPORTED. ON (B)(6) 2008, PATIENT VISITED FOR FOLLOW-UP . PATIENT IS EXPERIENCING ODD FEELING AND SOUND IN HIS LOWER BACK. X-RAYS SHOWS INTACT HARDWARE AND FUSION IN PROPER ALIGNMENT. (B)(6) 2008 , FOLLOW-UP VISIT. ON (B)(6) 2008 , FOLLOW-UP VISIT . PATIENT COMPLAINING BACK PAIN. IMPRESSION : LUMBAR DEGENERATIVE DISK DISEASE, DISKOGENIC PAIN . (B)(6) 2009 , PATIENT COMPLAINING NECK AND BACK PAIN. IMPRESSION: CERVICAL AND LUMBAR DISK HERNIATION. (B)(6) 2009 , FOLLOW UP VISIT. ON (B)(6) 2009, FOLLOW UP VISIT (B)(6) 2013, UNDERWENT MRI . RESULTS WERE OK. ON (B)(6) 2013, UNDERWENT MRI . RESULTS WERE OK (B)(6) 2012, PATIENT UNDERWENT CT SCAN. IMPRESSION: NORMAL CT SCAN OF THE PARANASAL SINUSES AND OTHER MAXILLOFACIAL STRUCTURES. ON (B)(6) 2012 , PATIENT UNDERWENT CBC, LIPID PANEL, AND OTHER TEST. ON (B)(6) 2012 , PATIENT CALLED FOR SCHEDULING APPOINTMENT. ON (B)(6) 2012 , PATIENT CALLED TO CONFIRM HIS APPOINTMENT FOR MRI. ON (B)(6) 2013, PATIENT CALLED TO DISCUSS ABOUT RESCHEDULING THE APPOINTMENT DATE. ON (B)(6) 2012 , PATIENT VISITED DEPARTMENT OF NEUROSURGERY AND UNDERWENT MRI OF THE LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION : STATUS POST INTERVERTEBRAL DISC PROSTHESIS PLACEMENT, POSTERIOR DECOMPRESSION, AND POSTERIOR FIXATION IN THE LOWER LUMBAR REGION. THERE IS NO STENOSIS OF THE SPINAL CANAL OR THE NEURAL FORAMINA. ON (B)(6) 2012, PATIENT UNDERWENT MRI AND CT. ON (B)(6) 2012, PATIENT PRESENTED WITH LABORATORY TEST REPORT. ON (B)(6) 2012 , PATIENT EXPERIENCING ABDOMINAL PAIN UNDERWENT US ABDOMEN . LIVER IS REPORTED AS FATTY BUT IN NORMAL SIZE. PATIENT STILL COMPLAINING OF PAIN ON HIS SIDE. ON (B)(6) 2012 , PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL LEG NUMBNESS, LEFT LEG WORSE THAN RIGHT LEG. HE UNDERWENT EXAMINATION (ELECTRODIAGNOSTIC ). IMPRESSION : CHRONIC LOW BACK PAIN WITH CHRONIC LEFT LS LUMBAR RADICULOPATHY (B)(6) 2012; ON (B)(6) 2013 , PATIENT VISITED FOR FOLLOW-UP. (B)(6) 2013, PATIENT VISITED FOR GENERAL CHECK UP. ON (B)(6) 2013, PATIENT PRESENTED WITH MID BACK PAIN UNDERWENT MRI . NO PATIENT COMPLICATION IS NOTED. ON (B)(6) 2013, PATIENT PRESENTED FOR CT SCAN . IMPRESSION: 4.2 X 3.0 CM PRESUMED BENIGN RIGHT HEPATIC LOBE HEMANGIOMA. ADDITIONAL 6-MONTH FOLLOW-UP LIVER PROTOCOL CT IS ADVISED TO ENSURE STABILITY. ON (B)(6) 2013 , PATIENT VISITED FOR F/UP TO GO OVER THE PROCESS AND RECOVERY OUTCOME OF REMOVING THE ROD THAT IS CAUSING HIS MUSCULAR PAIN . ON (B)(6) 2013, PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF HARDWARE FAILURE AT THE PREVIOUS INSTRUMENTATION SITE . THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) FOR ROC REMOVAL. POST OPERATIVELY THE PATIENT RECOVERED WELL, WAS AMBULATING INDEPENDENTLY, TOLERATING PO DIET, AND VOIDING WITHOUT DIFFICULTY. ON (B)(6) 2013, THE PATIENT UNDERWENT CT SPINE LUMBAR WITHOUT CONTRAST FOLLOWING HIS BACK PAIN. IMPRESSION: INTERVAL REMOVAL OF PEDICULAR SCREWS. OTHERWISE STABLE EXAMINATION . ON (B)(6) 2013, PATIENT WAS DISCHARGED FROM HOSPITAL . NO COMPLICATIONS REPORTED. ON (B)(6) 2013 , PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL EXTREMITY PAIN. HE HAS A CT SCAN AND MRI THAT SHOW THAT THE LEFT L2 CAP HAS COME OFF AND THAT THE ROD IS ELEVATED OUT OF THE TULIP OF THE SCREW WITH BONY GROWTH AROUND THAT. ON (B)(6) 2013 , PATIENT CALLED AND REPORTED SEVERE PAIN AFTER SURGERY. ON (B)(6) 2014, PATIENT PRESENTED FOR ULTRASOUND (US RUQ). IMPRESSION : NO ACUTE ABNORMALITY OF RIGHT UPPER QUADRANT ULTRASOUND NO GALLSTONES OR BILIARY DILATATION. HEPATOMEGALY AND FATTY INFILTRATION OF THE LIVER. ON (B)(6) 2014 , PATIENT PRESENTED FOR FOLLOW-UP ON (B)(6) 2014 , PATIENT UNDERWENT FOLLOWING DIAGNOSIS: STOMACH, ANTRAL BIOPSY. ASCENDING COLON, POLYP BIOPSY. HE UNDERWENT FOLLOWING OPERATIVE PROCEDURE EGD, COLONOSCOPY. PREOP DIAGNOSIS: REFLUX, ABDOMINAL PAIN . POST OP DIAGNOSIS: GASTRITIS, POLYP, HEMORRHOIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381046 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