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

Catalog Number 7510400

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

Patient Problems Abdominal Pain (1685); Arthritis (1723); Chest Pain (1776); Gastritis (1874); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Neuropathy (1983); Pain (1994); Hernia (2240); Stenosis (2263); Discomfort (2330); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544)

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

It was reported that on (b)(6) 2003: the patient presented with back pain.The patient underwent mri.Impressions: lumbar back pain with persistent pain requiring surgery.Chronic alcohol ingestion.Chronic nicotine ingestion.(b)(6) 2003: the patient presented with l4-l5 and l5-s1 intractable discogenic back pain.The patient underwent anterior lumbar interbody fusion, l4-l5 and l5-s1 via the anterior retroperitoneal exposure using two bone dowels packed with bone morphogenic protein in each level and they were threaded into good position after the holes were tapped.X-ray showed that everything was in good alignment.Then anterior instrumented stabilization of l5-s1 using a plate which was sized and positioned anterior to l5-s1 and secured with one screw in an oblique angle into the l5 vertebral body and two screws from an anterior to posterior direction through the plate in the sacrum.Posterior stabilization with instrumentation using one 4.5mm cannulated facet screw on the right and equation small-profile pedicle screws on the left was performed.Final ap and lateral x-rays were performed.The wound was covered with steri-strips and dry dressing.The patient underwent fluoroscopy for degenerative disc disease.Findings: two limited spot views of the lumbo sacral spine were submitted.No radiologists present for the procedure.Interpretation of spot films demonstrates fusion cage at l4-5 and l5-s1 with anterior fusion plate at l5-s1.No radiographic evidence of complication with respect to orthopedic or spinal hardware.Pre-op diagnosis: lumbar disc disease l4, l5, s1.The patient underwent anterior approach, retroperitoneal exposure, with mobilization of the infrarenal aorta and right and left common iliac arteries and veins.(b)(6) 2004: the patient presented with neck pain and numbness in legs.(b)(6) 2014: the patient presented with a lesion located on the left side of the neck that scabs over and drain.(b)(6) 2004: the patient presented with mild back pain.(b)(6) 2005: the patient presented with pain between shoulder <(>&<)> neck.(b)(6) 2005: the patient presented with chief complaint of latch in neck.(b)(6) 2005: the patient presented with mild back and neck pain.(b)(6) 2006: the patient presented with pain between shoulder and neck.(b)(6) 2007, (b)(6) 2008: the patient presented with neck and upper back pain.(b)(6) 2008: the patient presented with neck pain and shoulder pain.(b)(6) 2008: the patient presented for follow up visit.(b)(6) 2008: the patient presented for mri for cervical spine without contrast.Impressions: moderate cervical spondylosis, primarily from c4 through t1.Small disc osteophyte complex as well as facet joint and unconventional hypertrophy resulting in moderate foraminal stenosis bilaterally at c5-6 and c6-c7 as well as on the left of c7-t1.There is mild foraminal stenosis bilaterally at c4-c5 and c7-t1.There is no significant central canal stenosis.No spinal cord lesions are identified.(b)(6) 2008: the patient presented for electrodiagnostic evaluation.Impressions: cervical spondylosis.Subacute left neck pain.Intermittent left hand paresthesia.(b)(6) 2008: the patient presented for neck pain into left shoulder and brought mri reports.(b)(6) 2008: the patient presented with neck pain on left side.(b)(6) 2008: the patient presented with chief complaint of neck tightening on left.(b)(6) 2009: the patient presented with mild low back pain on left.(b)(6) 2009, (b)(6) 2010: the patient presented with mild back pain between shoulder blades and neck tightening.(b)(6) 2011: the patient presented with low back pain.(b)(6) 2014: the patient presented for follow-up visit and suture removal.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2010, patient presented with sudden onset of substernal chest pain radiating into his bilateral shoulders, back and jaw.Patient reported shortness of breath.Patient also underwent following procedure: left heart catheterization, coronary angiography, left ventricular angiogram.On (b)(6) 2010 patient presented for an office visit due to chest pain.On (b)(6) 2010 patient presented for an office visit due to his recent acute inferior myocardial infarction and subsequent catheterization which was very minimal coronary artery disease.Impression: acute inferolateral myocardial infarction treated with ¿tnk¿, mild coronary artery disease by recent catheterization, history of hyperlipidemia, history of gastroesophageal reflux disease, history of osteoarthritis.On (b)(6) 2011 patient presented for an office visit due to chest pain.Impression: recurring atypical chest pain, question angina, atherosclerotic coronary artery disease: a.History of acute inferolateral myocardial infarction treated with tnk, d.Only mild coronary artery disease at the time of the catheterization, history of hyperlipidemia, history of gastroesophageal reflux disease, history of osteoarthritis, history of significant psychosocial stress.On (b)(6) 2011 patient presented for an office visit due to umbilical hernia.Impression: umbilical hernia.On (b)(6) 2012: patient presented for office visit with pain lower neck into right scapula and into upper arm.Pain: achy, dull, deep.Pain radiates to right trapezius, right posterior scapula.Tightness in left and right cervical area, right trapezius.Spinal subluxation levels.Assessment: cervical pain and radicular pain.On (b)(6) 2013, (b)(6) 2014: patient presented for office visit with pain mid back lower neck into left shoulder, pain centered trap lower back and medial left scapula.Tightness in paraspinal muscles cervical and paraspinal muscles dorsal, right and left trapezius.Tenderness cervical paraspinal, dorsal paraspinal.Spinal subluxations found with motion palpation examination.Fixation hypertonic tissues.Assessment: cervicalgia, dorsal pain, multiple vertebral subluxation complexes.On (b)(6) 2014, patient presented for office visit for skin check.Patient reported a lesion on left side of neck that scabs over and drains.On (b)(6) 2014, patient presented for office visit with complaint of painful umbical hernia.On (b)(6) 2014, patient underwent following procedure: open umbical hernia repair with excision of that strangulated fat and gore bio a plug preperitoneal repair; for pre-op diagnosis of: incarcerated umbical hernia; and post-op diagnosis of: incarcerated, strangulated umbical hernia with necrotic, twisted omenial fat.Patient returned to recovery room in stable condition.On (b)(6) 2014, patient presented for first post-op office visit.On (b)(6) 2014, patient presented for follow-up on hypertension, hyperlipidemia and probable coronary artery disease.On (b)(6) 2015: patient presented for office visit with dull pain mid dorsal left side draws up to upper cervical, pain under left scapula, lot of heartburn last few weeks.Tightness in paraspinal muscles cervical and paraspinal muscles dorsal, right and left trapezius.Spinal subluxations found with motion palpation examination.Fixation hypertonic tissues.Assessment: cervicalgia, dorsal pain, multiple vertebral subluxation complexes.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5595401
• MDR Text Key: 43274353
• Report Number: 1030489-2016-01152
• 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: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: MB111008B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• 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 Weight: 92