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

Catalog Number 7510800

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

Patient Problems Anemia (1706); Asthma (1726); Chest Pain (1776); Congestive Heart Failure (1783); Dyspnea (1816); Edema (1820); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Pneumonia (2011); Respiratory Distress (2045); Scarring (2061); Seroma (2069); Swelling (2091); Vertigo (2134); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Tingling (2171); Cramp(s) (2193); Chronic Obstructive Pulmonary Disease (COPD) (2237); Myalgia (2238); Hernia (2240); Stenosis (2263); Urinary Frequency (2275); Injury (2348); Arthralgia (2355); Depression (2361); Numbness (2415); Chest Tightness/Pressure (2463); Ambulation Difficulties (2544); Dysuria (2684)

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterolateral fusion at l2-s1 using rhbmp-2/acs.Following surgery, the patient was seen for follow up.Reportedly, the patient developed increasing back pain and numbness and has difficulty walking.The patient continues to experience daily, disabling pain that prevents him from performing many activities of daily living.

Manufacturer Narrative

(b)(4): neither the device nor applicable imaging study films or patient medical records 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/used 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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2006: the patient complained of edema.Per billing records, the patient underwent x-rays of the chest.On (b)(6) 2007: per billing records, the patient underwent x-rays of the chest.(b)(6) 2007: per billing records, the patient underwent x-rays of the hip.On (b)(6) 2007: per billing records, the patient underwent ultrasound of testicles.On (b)(6) 2007: the patient presented six months status post left total hip arthroplasty.X-rays of the left hip were reviewed which showed good positioning of the prosthetic components.On (b)(6) 2008: per billing records, the patient underwent ct of lumbar spine.On (b)(6) 2009: the patient presented with left hip pain.X-rays were reviewed which showed good positioning of the prosthetic components.On (b)(6) 2010: the patient presented with increased left hip pain.On (b)(6) 2010: per billing records, the patient underwent x-ray of the hip.On (b)(6) 2011: x-rays were also reviewed which showed some tricompartmental osteoarthritic disease, mainly at the patellofemoral joint.On (b)(6) 2011: the patient underwent x-rays of the chest due to dyspnea.Impression: no acute or significant abnormality is identified.On (b)(6) 2012: the patient presented with low back pain with radicular symptoms.On (b)(6) 2013: per billing records, the patient underwent cardiac stress test.On (b)(6) 2013, and (b)(6) 2014, : the patient presented with low back pain radiating to left thigh, to the right thigh and bilateral hips.The pain was described as continuous, aching, burning and stabbing.Associated symptoms were weakness in the right leg and left leg.Aggravating factors included: any activity, prolonged positioning, sitting, standing and walking.Tenderness over sciatic notch was noted bilaterally.Tenderness over posterior superior iliac spine was also noted bilaterally.Musculoskeletal examination revealed myalgias, back pain and joint pain.Neurological examination revealed tingling.Psychiatric examination revealed insomnia and depression.Assessment: sacroilitis; postlaminectomy syndrome; degeneration of lumbar or lumbosacral intervertebral disc; spinal stenosis; low back pain; chronic hip pain.On (b)(6) 2013: the patient presented with left hip pain.The pain was described as an ache and throbbing.Symptoms were aggravated by active movement, lying down, prolonged standing.The patient was also experiencing decreased mobility, joint pain, limping, stiffness, tenderness and weakness.Per billing records, the patient underwent x-rays of the hip.On (b)(6) 2013: the patient presented with left hip pain.The pain was described as an ache and throbbing.Symptoms were aggravated by active movement, lying down, prolonged standing.The patient was also experiencing weakness.On (b)(6) 2013: the patient underwent ultrasound of the abdomen.Comments: difficult visualization and limited exam due to patient large body habitus and overlying bowel gas; liver: increased in echogenicity and prominent in size; gb: echogenic shadowing mobile material visualized; portal vein: hepatopetal flow demonstrated reverse direction of flow demonstrated during respiration.On (b)(6) 2014: the patient presented with numbness and tingling in the right hip and leg.On (b)(6) 2014: the patient presented with worsening left hip pain.The position of the pain was left posterior hip.The pain was described as an ache and throbbing.Symptoms were aggravated by active movement, passive movement and standing.He was also experiencing decreased mobility, stiffness, tenderness and weakness.On (b)(6) 2014: per billing records, the patient underwent x-rays of the chest.On (b)(6) 2014: per billing records, the patient underwent x-rays of the pelvis and hips.On (b)(6) 2014: the patient presented with the following diagnoses: stiffness of joint at pelvic region and thigh and muscle weakness.On (b)(6) 2014: per billing records, the patient underwent x-rays of the pelvis and hips.On (b)(6) 2014: the patient presented with the following diagnosis: left total hip revision.On (b)(6) 2015: the patient presented with urinary urgency and mild low back pain.On (b)(6) 2015: the patient presented with constant left hip pain.The location of the hip was anterior hip.The pain radiated to left thigh and was described as ache and throbbing.Symptoms were aggravated by sitting and standing.The patient was also experiencing right knee pain, which was aggravated by bending, climbing stairs and standing.Associated symptoms included crepitus, decreased mobility and difficulty going to sleep.On (b)(6) 2015: the patient presented for an office visit due to chronic hip pain, midline low back pain with sciatica and spinal stenosis.On (b)(6) 2015: the patient presented with low back pain.The pain was described as aching and throbbing.The pain was aggravated by standing and walking.Assessment: low back pain radiating to left leg.Long term current use of opiate analgesic.Status post lumbar surgery.Diabetes mellitus.Status post left hip replacement.On (b)(6) 2015: the patient underwent mri of lumbar spine due to low back pain and lower extremity pain.Impression: 3.2 x 6 x 2 cm fluid collection, likely hematoma/seroma; infection is not excluded; postsurgical change; moderate degenerative change.On (b)(6) 2015: the patient presented for an office visit for back pain.Diagnostic impression: axis i: major depression, history of anxiety, history of alcohol dependence.Axis ii: diagnosis deferred.Axis iii: diabetic neuropathy, failed back surgical syndrome.Axis iv: grandchildren's future.On (b)(6) 2012 the patient was presented for office visit.Impressions: diabetes, hypertension, congestive heart failure, chronic pain, low back pain, chronic hip pain, anxiety and depressions, sleep apnea, insomnia, copd.On (b)(6) 2012 the patient was presented for office visit with inguinal hernia, hypertension and chronic pain.On (b)(6) 2013 the patient was presented for office visit with back problems.Assessments: chronic left hip pain, diabetes, spinal stenosis, postlaminectomy syndrome, degeneration of lumbar or lumbosacral intervertebral disc, hypertension, copd, status post hip replacement.On (b)(6) 2013 the patient was presented for office visit.Assessments: chronic left hip pain, diabetes, spinal stenosis, postlaminectomy syndrome, degeneration of lumbar or lumbosacral intervertebral disc, hypertension, copd, status post hip replacement.On (b)(6) 2013 the patient was presented for office visit.Assessments: anemia, anxiety, depression, allergic rhinitis.On (b)(6) 2013 the patient was presented for office visit with hypertension, diabetes and back pain.On (b)(6) 2013 the patient was presented for office visit with dizziness and cough.Assessments: melena, diabetes, hypertension, hyperlipidemia anemia, copd, dizziness, bronchitis.On (b)(6) 2014: patient presented for follow up visit and complained of dry skin and skin rash.Assessments: dark urine, skin lesion of face, b12 deficiency, hyperlipidemia, anemia, diabetes, hypertension.On (b)(6) 2014: the patient presented for an office visit with hypertension and fatigue.Assessments: diabetes, left hip pain, congestive heart failure, hypertension.On (b)(6) 2015 the patient was presented for office visit with muscle pain.Assessments: type 2 diabetes, anemia, b12 deficiency, hyperlipidemia, hypertension, muscle cramp, postlaminectomy syndrome, spinal stenosis, degeneration of lumbar and lumbosacral intervertebral disc.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that on, (b)(6) 2000: the patient underwent x-ray spine, seven views.Impression: moderate spurring off the uncovertebral joints is present at c5-6 and c6-7 bilaterally.There is prominent ventral spurring from c4-c7 without prominent posterior spurring.No evidence of fracture or listhesis.(b)(6) 2000: the patient was admitted for right shoulder pain and numbness.Patient underwent mri cervical spine.Impression: there appears to be a left paracentral disc protusion at the c5-6 level as well as some evidence of unconvertible spurring, predominantly towards the right at c4-5 level.The degree of effacement to the central canal and neural foramina cannot be adequately evaluated due to lack of axial imaging.(b)(6) 2000: the patient presented with lower back pain radiating down to his left leg and with some tingling and paresthesia down in his left leg, and sometimes it was hard for him to walk.(b)(6) 2000: the patient underwent x-ray chest and left ribs.Impression: the heart is not enlarged.The aorta is normal.The lungs are free of acute disease.No pneumothorax or pleural fluid is seen.Left rib cage examination of the left rib cage shows some mild pleural thickening along the inner aspect of the left mid-hemithorax, but i cannot see obvious rib fracture.However, with this thickening, i would be at least suspicious of possible undisplaced rib fracture.(b)(6) 2001: patient underwent mri lumbar spine.Impression: degenerative changes are seen in all the l1-2 through l3-4 disks as des cribed with spinal canal narrowing seen most severely at l3-4 and l4-5 levels.Encroachment on the neural foramina is also seen at multiple levels but is probably most severe on left side of the l4-5 level and this appearance is unchanged from the earlier study.(b)(6) 2001, (b)(6) 2002, (b)(6) 2003: patient was admitted for paranoid type schizophrenia.(b)(6) 2001: the patient presented with precordial chest pain.(b)(6) 2001: the patient presented with "htn" and hypercholesterolemia.(b)(6) 2001: the patient presented with chronic obstructive pulmonary disease.Patient underwent chest x-ray, lateral and pa routine.Impression: normal chest.(b)(6) 2002: the patient presented with "htn" and hypercholesterolemia.19 may 2003: the patient presented with pure hypercholesterolemia.(b)(6) 2003: the patient presented with rash.(b)(6) 2003: the patient presented with diabetes.(b)(6) 2004, (b)(6) 2005: the patient presented with essential hypertension.(b)(6) 2004: the patient presented with low back pain.Patient underwent mri lumbar spine.Impression: overall similar appearance to the spine as compared with the 2001 study with multi-level degenerative changes as described above.(b)(6) 2004: the patient presented with anemia.(b)(6) 2005: patient presented with right shoulder pain.The patient underwent x-ray right shoulder, three views.Impression: no acute fracture or dislocation is seen.There is no radiopaque foreign body.(b)(6) 2005: patient presented with right arm pain and numbness.(b)(6) 2005: patient presented with leg swelling, carotid stenosis, arm pain and low ejection fraction.(b)(6) 2013: patient presented for colonoscopy.(b)(6) 2014: patient presented for x-ray hip, two views.Impression: degenerative changes without radiographic evidence of an acute fracture.Status post total left hip arthroplasty without radiographic evidence of loosening.(b)(6) 2014: per billing records, the patient underwent x-rays of the chest.Impression: no evidence for acute pulmonary process.

• 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: 4362833
• MDR Text Key: 15909714
• Report Number: 1030489-2014-04850
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M110812AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• 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