MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Injury (2348); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

Per medical records, it was reported that on (b)(6) 2011, the patient underwent x-ray of right knee.Impression : patellar fracture (b)(6) 2011 the patient underwent x-ray of right knee.(b)(6) 2011 the patient underwent x-rays of knees with three views due to closed fracture of right patella.X-rays showed minimal displacement of her fracture.(b)(6) 2011, (b)(6) 2011 the patient presented for an office visit due to low back pain.(b)(6) 2011 the patient presented for an office visit.X-rays of right knee showed no change in position of tibial components however displacement of the inferior pole of the patella remained.(b)(6) 2011 the patient presented for an office visit due to low back pain radiating into the legs.Impression: 1.Prominent degenerative facet changed with very focal and prominent abnormal spurring at the right posterior facet at l4-5.At l4-5 there was bilateral moderate foraminal narrowing approaching severe on the right and there was some central canal stenosis and garde-1 spondylolisthesis.2.At l5-s1 there are milder posterior facet degenerative changes creating mild foraminal narrowing on the right and mild to moderate narrowing on the left.(b)(6) 2011 the patient presented for an office visit due to low back pain.Patient had worst pain in the right side of buttock.The pain radiated down to the right leg.(b)(6) 2011 the patient underwent x-ray of chest.(b)(6) 2011 the patient presented for an office visit.(b)(6) 2011 the patient presented with right patella fracture status post right total knee replacement with loose patellar component.The patient underwent patellectomy of right knee.(b)(6) 2011 the patient presented for an office visit with chief complaint of back and bilateral leg pain.(b)(6) 2012 the patient presented for an office visit due to right leg pain.Radio graphs showed excellent position of all prosthetic components.(b)(6) 2012 the patient presented for an office visit with primary problem of the low back pain.(b)(6) 2012 the patient presented with chief complaint of bp problem.(b)(6) 2012 the patient presented with chief complaint of back and leg pain.(b)(6) 2012 the patient presented with chief complaint of back pain.(b)(6) 2012 the patient presented with chief complaint of back pain.Patient presented for pre-op evaluation.Review of system: neurological- feeling weak, psychiatric insomnia, anxiety and depression.(b)(6) 2012 the patient presented for medication follow up.(b)(6) 2012 the patient presented with degenerative spondylolisthesis and spinal stenosis l4-5.The patient underwent laminectomy l4-5, transforaminal lumbar interbody fusion l4-5 using tangent allograft rhbmp-2 and local bone graft and pedicle screw rod and fixation.Per-op notes: surgeon removed the disk, and inserted a 10 mm x 20mm allograft into the intervertebral disk space and recessed it about 7mm anterior to the posterior wall of l5.Surgeon inserted an rhbmp-2 sponge into the intervertebral disk space.The rhbmp-2 sponge was 4 mg in size.Surgeon pushed it to the anterior one third of the vertebral body sitting anterior to the opposite side tangent.Surgeon packed the center portion of the disk space as tightly as possible with the local bone graft.Surgeon then inserted 10mm x 20 mm tangent allograft into the intervertebral disk space on the left side.(b)(6) 2012 the patient presented with primary problem of her low back pain.(b)(6) 2012, the patient presented for the patient presented for follow up of laminectomy, transforaminal lumbar interbody fusion and posterolateral spinal fusion of l4-5.Radiographs showed the post operative hardware to be intact and well positioned without evidence of loosening or failure, the interbody bone graft is well positioned and intact without evidence of significant subsidence or displacement.Patient complained low back pain.(b)(6) 2012 the patient presented with low back pain and leg pain.(b)(6) 2012 the patient presented with chief complaint of chest pain.(b)(6) 2012 the patient presented with chief complaint of chest pain, shortness of breath and low back pain and right leg pain.The patient underwent the pharmacologic stress electrocardiography.(b)(6) 2012 the patient underwent x-rays of knee right 3 views.X-rays showed no changes in the position of prosthetic component.(b)(6) 2012 the patient presented for follow up.(b)(6) 2012 the patient presented for follow up of laminectomy, transforaminal lumbar interbody fusion and posterolateral spinal fusion of l4-5.Patient complained of leg pain centered around the knee on the right.She had back pain on the right side of the lower back.(b)(6) 2012 the patient underwent x-rays of right knee.Three x-rays of right knee showed excellent position of all prosthetic components with no interface radiolucency.(b)(6) 2012 the patient presented with chief complaint of low back and right leg pain.(b)(6) 2012 the patient presented with chief complaint of right low back pain radiating into right buttock and intermittently into the posterior thigh.(b)(6) 2012 the patient presented with low back pain and right leg pain.(b)(6) 2012 the patient presented for follow up of benign hypertension.Review of system: musculoskeletal - back pain, arthralgia ;psychiatric- anxiety, depression, stress.(b)(6) 2012, the patient underwent the procedure of right si joint steroid injection under fluoroscopic guidance.(b)(6) 2012 the patient presented with right si joint pain.(b)(6) 2012 the patient underwent x-rays of right knee with 3 views due to knee pain.(b)(6) 2012 the patient presented for an office visit due to unchanged range of motion.(b)(6) 2012 the patient presented with chief complaint of low back and leg pain, fatigue, depression.(b)(6) 2012 the patient presented with chief complaint of low back and leg pain.(b)(6) 2012 the patient presented for an office visit due to swelling about her anterior of her knee.(b)(6) 2012 the patient presented with chief complaint of fatigue , back and leg pain, follow up of arthralgia, multiple sites.Review of system: musculoskeletal- tender across upper back, knee bursa; neurological: mild limp, absent reflexes in knees and ankles bilaterally.(b)(6) 2013 the patient presented with chief complaints of her back pain and right leg pain.(b)(6) 2013 the patient presented with chief complaint of left leg pain.Impression: occlusive dvt was noted within the left popliteal vein and the visualized portions of an anterior tibial vein.The patient underwent radio graphic test of left tibia and fibula.Due to shin pain, and history of stress fractures.Impression: 1.Negative for an acute fracture or dislocation.2.Patellofemoral compartment djd was noted.3.Unremarkable soft tissues.4.Periosteal reaction was noted along the lateral aspect of mid fibular diaphysis.(b)(6) 2013 the patient presented with chief complaint of blood clots in leg.(b)(6) 2013 the patient presented with chief complaints of facial numbness; walk in.Review of system: neurological-dizziness, numbness in face.(b)(6) 2013 the patient presented for follow up for bells plasty, deep venous thrombosis in leg, fatigue.(b)(6) 2013 the patient presented for an office visit.Patient stated that clothes hurt her skin, neck hurts.(b)(6) 2013 the patient presented for an office visit.Patient complained that her skin was tight and painful involving her whole body.Patient also complained of headache and minor neck pain.(b)(6) 2013 the patient presented with swelling in her leg.Patient underwent ct scan of knee due to pain in right knee.(b)(6) 2013 the patient presented for an office visit.Patient underwent the injection in the pes bursa.(b)(6) 2013 the patient presented with chief complaints of blood clot at left leg, dizziness.The patient underwent ultrasound of left low extremity.Impression: no evidence of deep venous thrombosis.(b)(6) 2013 the patient underwent myelogram/ct scan of lumbar spine.Radiographic: ap lateral spine with flexion extension views demonstrated solid fusion at l4-5 with no evidence of any complication or adjacent segment abnormality.(b)(6) 2013 the patient presented for follow up due to pain.Impression: ectopic spinal canal bone formation with neural eructation.(b)(6) 2013 the patient presented with chief complaint of dizzy, weakness, headache, muscle aches.Review of systems: musculoskeletal -joint pain, muscle aches, muscle cramps.(b)(6) 2013 the patient presented with chief complaints of back pain, decrease "loc".(b)(6) 2013, the patient presented for an office visit.Review of systems: musculoskeletal- joint pain, muscle pain, back pain.Neuro logical- dizziness.Psychiatric.Feels sad, down depressed, lack of interest in activities.(b)(6) 2013 the patient presented for follow up of personal history of transient ischemic attack, and cerebral infarction, syndrome of lower limbs.(b)(6) 2013 the patient presented with discomfort in her knees and back.(b)(6) 2013 the patient presented for an office visit with chief complaint of memory loss.(b)(6) 2013 the patient presented for office visit.Patient complained of having episodes in which patient become shaky and inability to concentrate.(b)(6) 2013 the patient admitted to hospital due to weakness in both legs and episodes.Patient discharged with following diagnosis: polypharmacy with medication induced symptoms.(b)(6) 2013 the presented with episode of altered mental status.Impression: normal eeg, 2.Patient had one of her spells.Patient described headache and shaking activity with a normal eeg.(b)(6) 2013 the patient presented for office visit.(b)(6) 2013 the patient presented for an office visit due to chief complaints of back pain and right leg pain.(b)(6) 2013 the patient presented with chief complaints of body ache, fever, fatigue, vaginal pain and bleeding, kidney infection.(b)(6) 2013 the patient presented with chief complaint for vaginal bleeding.Review of system: musculoskeletal "history of back pain, found bone still growing and resting on the nerves in her spinal cord.(b)(6) 2013 the patient underwent ultrasound of pelvic and transvaginal.Impression: 1.No pelvic mass or free fluid.2.Left ovary not visualized.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5256625
• MDR Text Key: 32392522
• Report Number: 1030489-2015-03275
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 114