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

Catalog Number 7510200

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

Patient Problems Arthritis (1723); Breast Cancer (1759); Chest Pain (1776); Cyst(s) (1800); Edema (1820); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Thyroid Problems (2102); Weakness (2145); Tingling (2171); Numbness (2415); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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

It was reported that on, on (b)(6) 2009 the patient underwent x-ray of lumbosacral spine.Impression: l4-l5 fusion without complicating features.On (b)(6) 2009 the patient underwent x-ray of lumbosacral spine.Impression: l4-l5 fusion without complicating features.On (b)(6) 2009 patient underwent thyroid uptake/scan due to hyperthyroidism, 2 nodule.Impression: 1.4 and 25 hours uptake values w ere 5.2 and 17.7% respectively both within the normal range but within the lower level of normal.2.Negative thyroid scanning with no focal uptake abnormalities are normal in size.The patient underwent mri of lumbar spine with/without contrast.Impression: postsurgical changes at l4-l5 with left sided pedicular screw and rod as well as bone cage at the disc level.There was some enhancing tissue at the left-sided neural foramen but no significant central canal or neural foraminal narrowing on the right.(b)(6) 2012 the patient underwent x-ray of dorsal spine.Impression :negative thoracic spine series.No fracture.(b)(6) 2013 the paint underwent x-ray of lumbosacral spine.Impression: no fractures or bone destructive process.Mild multilevel lumbar spondylosis as noted, postsurgical change as noted, without radiographic evidence of complication.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2009, the patient presented for follow-up and laboratory reports.On (b)(6) 2009, the patient presented with swelling leg.On (b)(6) 2009 patient underwent biliary tech-hida with stimulation due to abdomen pain.Impression: no evidence for acute cholecystitis or complete biliary obstruction.Borderline abnormal gallbladder ejection fraction with pain and nausea during cck infusion, could represent an element of gallbladder dysfunction and chronic cholecystitis.The patient underwent x-ray of lumbosacral spine.Impression: l4-l5 fusion without complicating features.On (b)(6) 2009 the patient presented for post-op visit.Impression : l4-l5 fusion without complicating features.The patient underwent x-ray of lumbosacral spine.Impression: l4-l5 fusion without complicating features.On (b)(6) 2009, the patient presented with back pain and requested for medicine refill.On (b)(6) 2009 patient underwent thyroid uptake/scan due to hyperthyroidism, 2 nodule.Impression: 4 and 25 hours uptake values were 5.2 and 17.7% respectively both within the normal range but within the lower level of normal; negative thyroid scanning with no focal uptake abnormalities are normal in size.The patient underwent mri of lumbar spine with/without contrast.Impression: postsurgical changes at l4-l5 with left sided pedicular screw and rod as well as bone cage at the disc level.There was some enhancing tissue at the left-sided neural foramen but no significant central canal or neural foraminal narrowing on the right.On (b)(6) 2010, the patient presented for follow-up and report evaluation.On (b)(6) 2010, the patient presented with back pain and requested for medicine refill.On (b)(6) 2010, the patient presented with flu symptoms.On (b)(6) 2010, the patient presented with mva shoulder and back pain.On (b)(6) 2010, the patient presented with chest pain.Impression: no active chest disease.The lungs are clear.On (b)(6) 2010, the patient presented for follow-up.On (b)(6) 2010, the patient presented for office visit/crud.On (b)(6) 11, the patient presented with lipid panel report , cmp.On (b)(6) 2011, the patient presented with depression (b)(6) 2011, the patient presented with right arm pain.On (b)(6) 2011 (b)(6) 2012, the patient presented for laboratory examination.On (b)(6) 2011 <(>&<)> (b)(6) 2012 , the patient presented with cough and loss of voice, back pain.Impression ((b)(6) 2012): negative thoracic spine series.No fracture seen.Impression ( (b)(6) 2011): no active chest disease.The lungs are clear.On (b)(6) 2012 the patient underwent x-ray of dorsal spine.Impression :negative thoracic spine series.No fracture.On (b)(6) 2012, the patient presented for medicine refill.10/10/12, the patient presented with injury due to falling.On (b)(6) 2013: the patient presented for follow-up visit with breast cancer.Assessment: breast cancer and anemia.On (b)(6) 2013, the patient presented for treatment of sinus/throat.The patient underwent cbc with differential.On (b)(6) 2013, the patient presented for pain contract underwent lumbosacral spine x-ray.Impression : no fracture or bone destructive process.Mild multilevel lumbar spondylosis as noted.Postsurgical change as noted, without radiographic evidence of complication (b)(6) 2014, the patient presented with flu symptoms.Impression: no active chest disease.On (b)(6) 2013 <(>&<)> (b)(6) 2014, the patient presented with chief complaint of migraine.Impression : postsurgical changes at l4-l5 with left-sided pedicular screw and rod as well as bone cage at the disc level.There is some enhancing tissue at the left-sided neural foramen but no significant central canal or neural foraminal narrowing on the right done physical therapy.Home exercising, including walking (b)(6) 2014, the patient presented for lipid panel test , tsh.On (b)(6) 2014, the patient presented for follow up.She underwent physical examination.On (b)(6) 2015, the patient presented for culture test lab report.On (b)(6) 2015, the patient presented for medicine refill.

Event Description

It was reported that on, (b)(6) 2001: patient underwent for left mammogram test.Impression: suspicious microcalcification medial upper left breast.No associated mass can be identified.The calcifications do represent a cluster of small calcifications and are suspicious.On (b)(6) 2005: patient presented with chief complaint of congestion.On (b)(6) 2006: patient underwent mammo screening.Impression: right breast ultrasound is recommended for nodular density upper outer quadrant.Problem-solving views of the left breast for calcifications are needed.On (b)(6) 2006: patient underwent right breast ultrasound.Impression: findings in the right breast by ultrasound are benign with a benign cyst; findings in the left breast are birads iv-suspicious with two areas, of microcalcification which have developed since (b)(6) 2001 and biopsy is felt indicated (b)(6) 2008: patient underwent ct, lumbar spine.Impression: adequate placement of a left l4 and l5 pedicle screw placement with a bone cage at the l4-5 level.On (b)(6) 2008: patient presented with chief complaint of allergic reactions due to coconut.On (b)(6) 2008: patient presented with chief complaint of back pain.On (b)(6) 2010: patient received findings in the core needle biopsy from the right breast nodule discovered.Diagnosis: breast, nodule at 10 o¿clock, core needle biopsy.Tubular carcinoma.On (b)(6) 2011: patient presented with crying spells, anxiety.Diagnosis: acute stress reaction, history of depression, cancer, breast.On (b)(6) 2011: patient presented for an office visit due to complaint of foreign body, eye.Diagnosis: cornea abrasion.

Event Description

It was reported that on, (b)(6) 2008: the patient underwent x-ray of chest posterior anterior and lateral.Findings: heart size is normal.Pulmonary vascularity is normal.The trachea is midline.The lungs are clear.No pleural fluid seen.Regional osseous structures are intact.On (b)(6) 2009: the patient underwent x-ray of chest.On (b)(6) 2009: the patient underwent ultrasound due to thyroid.Impression: the thyroid gland size is normal.There are two tiny hypo-echoic nodules within the left lobe of the thyroid measuring 2.5 and 2 mm.If there is need for documentation of hypothyroidism this can be correlated with a nuclear medicine thyroid uptake and imaging study.On (b)(6) 2009: patient underwent thyroid uptake/scan due to hyperthyroidism, 2 nodule.Impression: 4 and 25 hours uptake values were 5.2 and 17.7% respectively both within the normal range but within the lower level of normal.Negative thyroid scanning with no focal uptake abnormalities are normal in size.The patient underwent mri of lumbar spine with/without contrast.Impression: postsurgical changes at l4-l5 with left sided pedicular screw and rod as well as bone cage at the disc level.There was some enhancing tissue at the left-sided neural foramen but no significant central canal or neural foraminal narrowing on the right.On (b)(6) 2010: the patient underwent x-ray of chest posterior anterior and lateral.Impression: no active chest disease.The lungs are clear.On (b)(6) 2010: the patient underwent x-ray of bilateral hips.Impression: no acute radiographic abnormality identified.On (b)(6) 2011: the underwent x-ray of right shoulder.Impression: no acute fracture, dislocation or bone destructive process.On (b)(6) 2011: the patient underwent x-ray of chest posterior anterior and lateral due to history of cough and congestion.Impression: no active chest disease.The lungs are clear.On (b)(6) 2012: the patient underwent x-ray of chest posterior anterior and lateral.Impression: no active chest disease.The lungs are clear.On (b)(6) 2012 the patient underwent x-ray of dorsal spine.Impression: negative thoracic spine series.No fracture.The patient also underwent x-ray of ribs and right side due to history of pain.Impression: no displaced fractures or dislocations are seen involving the right ribs.Underlying right lung is clear.No pneumothorax is seen.On (b)(6) 2012: the patient underwent x-ray of chest posterior anterior and lateral due to trouble in breathing.Impression: no active chest disease.The lungs are clear.On (b)(6) 2012: the patient presented for x-ray of neck soft tissue due to swollen throat and loss of voice.Impression: unremarkable patency of upper airway.On (b)(6) 2014: the patient underwent x-ray of chest posterior anterior and lateral due to cough.Impression: no active chest disease.On (b)(6) 2014: the patient also underwent x-ray of cervical spine anterior posterior and lateral.Impression: no evidence of an acute injury to the cervical spine radiographically.Biomechanical degenerative changes of the cervical spine.

• 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: 5209806
• MDR Text Key: 30691046
• Report Number: 1030489-2015-02959
• 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,Followup,Followup,Followup
• Report Date: 04/08/2016

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
• Device Catalogue Number: 7510200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2015; 03/02/2016; 05/04/2016
• 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