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 Cardiomyopathy (1764); Chest Pain (1776); Dyspnea (1816); Edema (1820); Fatigue (1849); Headache (1880); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Seroma (2069); Swelling (2091); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Stenosis (2263); Discomfort (2330); Arthralgia (2355); Depression (2361); Numbness (2415); Neck Pain (2433); Palpitations (2467); Shaking/Tremors (2515)

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) 2005 the patient presented due to postop anterior spinal fusion at ls-s.Impression: postop changes.Posterior spinal fusion at ls-s1 on the left.Good position and alignment.On (b)(6) 2008; (b)(6) 2006; (b)(6) 2005, the patient presented for follow up.On (b)(6) 2008, per medical bills, the patient was admitted for anterior / posterior lumbar or lumbosacral fusion.The patient had removal of implant device and fusion/refusion of 2-3 vertebrae.Recombinant bmp was used for insert.Billing records confirm used of set screws, rhbmp/2, lined rod.On (b)(6) 2009 the patient presented for routine check and underwent bilateral mammograms.Impression: category 2.Benign findings.On (b)(6) 2012 the patient presented to the office for her annual exam.On (b)(6) 2014 the patient presented to the office for her annual exam and hormone refills.On (b)(6) 2014:.The patient underwent digital bilateral mammography.Impression: benign mammograms, category 2.On (b)(6) 2015 the patient presented to the office for her annual exam.On (b)(6) 2015 the patient presented to the office to undergo lab tests.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2008 the patient presented to the office for physical therapy.On (b)(6) 2008 the patient underwent physical therapy neck, lumbago, arthrodesis status.On (b)(6) 2008 the patient presented to the office for physical therapy.On (b)(6) 2008 the patient presented with chief complaint of low back pain.On (b)(6) 2009 the patient presented for a medical exam, open wound of cheek, swelling in head and neck, chronic pain syndrome, arthropathy nos-unspec, depressive disorder neck, c.A.T.Scan of head.The patient underwent ct of the facial bones without contrast with coronal reformats.Impression: no acute fracture identified.Left periorbital preseptal cellulitis suspected.On (b)(6) 2009 the patient presented for office visit with lumbar puncture reaction, cervicalgia, nausea with vomiting, esophageal reflux, backache nos, chronic pain.On (b)(6) 2010 the patient underwent anesthesis procedure.The patient had diagnosis of primary cardiomyopathy, mitral valve disorder, coronary artery anomaly, tricuspid valve disease, hypertension, esophageal reflux, tobacco use disorder, backache nos.The patient presented for dx ultrasound-heart.On (b)(6) 2010 patient presented for medications.On (b)(6) 2010 the patient presented with chief complaint of primary cardiomyopathy.The patient underwent c.A.T.Scan of thorax.On (b)(6) 2010 the patient presented with chief complaint of dizziness, giddiness and anxiety.On (b)(6) 2010 the patient presented with complaint of chest pain, painful respiration, hypertension.On (b)(6) 2011 patient presented with chief complaint of abdominal pain, fever, chills, general weakness, acute gastroenteritis.Pain had cramping, throbbing pain in epigastric area.On (b)(6) 2011 patient presented for an office visit with chief diagnosis ¿noninf gastroenterit nec¿, acute kidney failure, primary cardiomyopathy, dehydration, hypotension, hypertension, intestine disorders, esophageal reflux, chronic pain syndrome, backache, gastroparesis, irritable bowel syndrome.On (b)(6) 2011 patient underwent radiology exam due to recurrent nausea/vomiting.Impression: postoperative changes.Nonspecific bowel gas pattern; satisfactory positioning of the picc line.No acute cardiopulmonary pathology.On (b)(6) 2011 the patient presented for medications.On (b)(6) 2011 the patient presented for neurological assessment.The patient underwent ct head without contrast ¿¿recurrent n/v¿ per s tretcher.Impression: mild nonspecific low attenuation within the periventricular white matter, particularly on the right which is not significantly changed from 2005 and most likely represents changes of chronic microvascular ischemia; focal area of increased attenuation within the left basal ganglia.This most likely represents physiologic calcification, however is somewhat asymmetric from the right basal ganglia.Attention should be given on short interval follow-up exam.Patient also underwent ct of abdomen and pelvis without contrast.Impression: no evidence of bowel obstruction; moderately distended urinary bladder; prior posterior fusion extending from l4 through s1 on the right and at the l4 and l5 levels on the left; previous cholecystectomy; postoperative changes within the anterolateral right abdominal wall with an approximately 1.5 cm fluid collection just superficial to the rectus fascia which most likely represents a postoperative hematoma or seroma.Patient was diagnosed with gastroenteritis, dehydration, hypertension, leukocytosis, hypokalemia.Patient underwent ecg (b)(6) 2011 patient presented for medications.Patient underwent stimulation test.Patient underwent ct of abdomen/ pelvis.Impression: no evidence of bowel obstruction; moderately distended urinary bladder; prior posterior fusion l4-s1 on right and l4 and l5 on left; previous cholecystectomy; postop within the anterolateral right above all with an approximate 1.5 cm fluid collection just superficial to the rectus fascia which most likely represents a postop hematoma or seroma.On (b)(6) 2011 patient had some pain.On (b)(6) 2011 patient presented for medications.On (b)(6) 2011 patient presented for an office visit.On (b)(6) 2012 the patient underwent ¿icd¿ procedure.On (b)(6) 2012 the patient underwent aicd procedure.The patient was assessed for severe cardiomyopathy, anomalous left vein, moderate to severe mitral regurgitation, hypertension, ventricle ectopy, moderate pulmonary hypertension.The patient underwent cardioverter defibrillator implantation with acute placement of a right ventricular defibrillator lead.The patient underwent chest portable exam.Impression: interval placement of a defibrillator.No pneumothorax; hazy appearance in the region of the left upper lung field, possibly representing underlying atelectasis or infiltrate.Review of system revealed: high blood pressure, heart disease.Patient underwent echocardiogram.On (b)(6) 2012 the patient underwent pa and lateral chest.A defibrillator overlies the left chest.The heart is mildly enlarged.Imp ression: no acute process.Patient presented with cardiology problems.On (b)(6) 2012 the patient presented for office visit.On (b)(6) 2012 patient presented for an office visit.Patient underwent screening of mammogram.Impressions: benign mammograms.On (b)(6) 2014 the patient presented for low back pain.On (b)(6) 2014 the patient presented to the office for physical therapy due to actual or suspected pain in the lumbar region.On (b)(6) 2014 the patient presented with chief complaint of cardiac abnormality.On (b)(6) 2014 the patient presented for low back pain, cardiac abnormality.On (b)(6) 2014 the patient presented for physical therapy due to actual or suspected pain in the lumbar region.The patient complaints of pain with exercises.On (b)(6) 2014 the patient presented with suspected low back pain and getting sick with flu.On (b)(6) 2014 the patient presented for actual or suspected low back pain.On (b)(6) 2014 the patient presented with chief complaint of cardiac abnormality.The patient underwent routine ma screening mammogram which indicated benign mammograms-category 2(computer aided detection was utilized in the interpretation of the exam), patient did not allow ideal positioning on the left due to defibrillator, there was mild to moderate breast density with no dominant mass, benign calcifications were present.On (b)(6) 2014 the patient presented to the office for physical therapy due to actual or suspected pain in the lumbar region.Patient also reported cardiac abnormality (b)(6) 2014 the patient presented for physical therapy (aquatic therex)), assessment indicated increased pain in the lumbar region of the patient.On (b)(6) 2014 the patient presented for aquatic therex (physical therapy) due to actual or suspected pain in the lumbar region of the patient.On (b)(6) 2014 the patient presented with chief complaint of cardiac abnormality.On (b)(6) 2014 the patient underwent the procedure of injection and infusion of other therapeutic or prophylactic.On (b)(6) 2014 the patient underwent thoracic spine, three view.Due to thoracic spine pain.Mild disc space narrowing and hypertrophic ridging was noted throughout the thoracic spine, greater in the mid to lower thoracic spine region.Impression: degenerative changes.On (b)(6) 2014 the patient presented with chief complaint of cardiac abnormality, abdominal pain, diarrhea, nausea, vomiting, trauma.On (b)(6) 2015 the patient presented with chief complaint of cardiac abnormality, abdominal pain, nausea, trauma, gastroenteritis, uti (urinary tract infection).The patient underwent dx abd series w/pa chst due to abdominal pain and vomiting.Impression: improved chf/fluid overload from (b)(6) 2015.Ros revealed: back pain and chronic lower back pain.On (b)(6) 2015 the patient had mammogram comparison from (b)(6) 2014 and (b)(6) 2012.Impression: benign findings.Routine annual follow-up mammogram is recommended.On (b)(6) 2016 patient presented for lumbago and arthrodesis.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on, (b)(6) 2015: patient underwent pa chest x-ray due to abdominal pain.Impression: chf/fluid overload.On (b)(6) 2016: patient underwent pa and lateral chest.Impression: cardiomegaly.

• 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: 5313186
• MDR Text Key: 33936286
• Report Number: 1030489-2015-03520
• 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
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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
• Date Manufacturer Received: 04/28/2016
• 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
• Patient Age: 00043 YR
• Patient Weight: 75