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 Anemia (1706); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pain (1994); Tingling (2171); Stenosis (2263); Injury (2348); Hypoesthesia (2352); Neck Pain (2433)

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.

Event Description

It was reported that on (b)(6) 2008: the patient presented with facial drawing /numbness.On (b)(6) 2009: the patient presented with chief complaint of back injury.On (b)(6) 2009: the patient presented with chief complaint of poss stroke.On (b)(6) 2009: the patient presented with back pain with bilateral lower extremity pain.The patient underwent physical examination.Musculoskeletal: examination reveals limited range of motion both in the cervical and lumbar spine but in particular was lumbar range of motion severely limited with both flexion and extension, stance reveals some mild flexion and this was preferred by the patient.Lumbosacral palpable tenderness was found in the paraspinals, no trigger points were noted.Neurologic: neurological examination reveals symmetrical reflexes except for her left biceps which was 1+ compared to 2+ on the right.Sensory examination to light touch reveals negative straight leg raising but slightly decreased sensation in both l5 dermatomes.The patient underwent mri of cervical.Impression: bilateral l5 radiculopathy secondary to degenerative spondylolisthesis.Chronic back pain secondary to degenerative disc disease at l4-l5 and l5-s1 with facet arthropathy.Degenerative disc disease of the cervical spine with chronic pain history.Mri documented advanced degenerative disc disease, c5-c6 and c6-c7 with suspected clinical left c6 radiculopathy.On (b)(6) 2009: the patient presented with preoperative diagnosis of failed back surgery and degenerative disk disease and radiculopathy.The patient underwent revision laminectomy l5-s1 on the left with decompression and transforaminal lumbar interbody fusion, transforaminal lumbar interbody fusion l4-5, instrumentation with l4-s1 and interbody cages, bp and local bone graft.Per op notes: the patient was taken to the operating room and was given the anesthesia.A 3cm incision was then made between l4-s1 4.5cm from the midline first on the left.The soft tissue was cleaned off the facet and the facet was then removed on the left at l5-s1 with an osteotome and kerrison rongeurs.The disk space was quite stiff secondary to previous scarring.Once this was completed, a bone graft and bone matrix protein was packed in the cage and bone graft within the interspace and the cage then impacted into the interspace while protecting the nerve root and dura.Curettes were also used to remove the cartilaginous endplates along with pituitary rongeurs.After thorough irrigation a size 12 cage was then impacted in to position after packing the interspace.The cage was filled with bmp.The retractors were then removed after placing the episeal over the laminotomy site.The screws were then placed bilaterally with instrumentation in as standard fashion and a rod placed subcutaneously.The patient underwent x-ray ap and lateral of lumbar spine.Findings: implants have no evidence of any loosening, no subsidence and good grafting material within the interspace at l4-5 and 5-1.On (b)(6) 2009: the patient was discharged with discharged diagnosis of constipation, asthma, anxiety, anemia, hyperlipidemia, and hypertension.On (b)(6) 2009: the patient presented with bilateral knee pain and underwent radiology examination of knee bilateral ap.Findings: four views of the right knee show what was likely a subchondral cyst in the undersurface of the articular mid patella from perhaps a costochondral defect.Consider right knee mri.Right knee.Otherwise negative.The three views of the left knee shows very mild: medial compartmental narrowing.No other abnormality seen.Impressions: transient penetration with thin liquids.Negative for aspiration.Prior cervical fusion.No esophageal obstruction.On (b)(6) 2009: the patient presented with reinjury to lower back with right anterior leg pain.X-ray revealed two months postop l4 to s1 minimally invasive posterior spinal fusion with recent flare-up of back pain due to recent trauma.Long-term preoperative and significant narcotic use.On (b)(6) 2009: the patient presented for follow-up.Mri revealed severe degenerative disc disease c5-6 and c6-7 with posterior disc osteophyte ridge and foraminal narrowing, recommendation would be for an acf c5-6 and c6-7, if she wishes to proceed with this, she can return to see my assistant, (b)(6), for final 'h<(>&<)>p'.On (b)(6) 2009: the patient presented with chief complaint of neck pain and left shoulder pain.Ros revealed: musculoskeletal: exam reveals painful cervical range of motion with posterior stretch noted on flexion.There was a palpable tenderness that was 2+ in the posterior cervical region and suprascapular area bilaterally.Some spasm was found in the left trapezius but no definite trigger points were appreciated.Neurological exam reveals hypoesthesia in the lateral aspect of the left forearm and the left thumb.There was a positive phalen test on the left side within 30 seconds.Reflexes were symmetrical and no diagnostic.Motors show symmetrical 5- weakness of both upper extremities.On (b)(6) 2009: the patient presented with chief complaint of poss, uti.On (b)(6) 2009: the patient presented with chest pain and shortness of breath.The patient underwent rad/xr chest 1 view.Impressions: no acute findings.On (b)(6) 2009: the patient presented with bronchitis and hypertension the patient underwent x-ray of chest.Impressions: negative chest.On (b)(6) 2009: the patient presented for follow up visit.On (b)(6) 2009: the patient presented with neck pain and underwent x-ray of c-spine.Findings: films show evidence of a into discectomy and fusion at c5-6 and c6-1.The hardware and disc spacers appear to be in good position.On (b)(6) 2009: the patient presented with asthma, pharyngitis and shortness of breath.The patient underwent radiology examination of pa and lateral chest.Impressions: negative two view chest.No infiltrate or consolidation.No pneumothorax or infiltrate.On (b)(6) 2010: then patient presented for follow up visit with x rays reports of cervical.Findings: she also had x-rays of the cervical spine showing no fractures.She had a slight anterolisthesis of c3 on c4.On (b)(6) 2010: the patient presented with chest wall pain and underwent radiology examination of chest pa and lateral.Findings: there had been prior cervicothoracic plate-and-screw fusion and there was also evidence of lumbar surgical change at the inferior extend of the examination.The heart size was normal.Negative for pneumothorax.Lungs were clear.An additional view of the left ribs shows no displaced fracture.Overall, no acute disease.On (b)(6) 2010: the patient presented with pre-operative diagnosis of red rectal bleeding, history of colon polyps and underwent colonoscopy.The patient underwent endoscopy.On (b)(6) 2011: the patient was discharged with discharge diagnoses:- chest pain, fibromyalgia, anxiety, gastroesophageal reflux disease, chronic pain, hypertension.On (b)(6) 2011: the patients presented with cough/wheezing.On (b)(6) 2011: the patient underwent mri of cervical and lumbar.Impressions: weakness in the upper and lower extremities with paresthesias.We have ruled out any type of cervical myelopathy.She does have a minimal amount of lumbar stenosis at the level adjacent to her fusion at l3-4; however, her complaints were not indicative of neurogenic claudication.We were unsure as to the exact etiology of her multifactorial complaint.She had been worked up for cardiac issues as well as a cva and all of these have been negative.Therefore, we were going to consult her primary care physician and also ask neurology to see her to rule out any type of new neurological issues and we were going to obtain an mri of the thoracic spine to rule out any spinal cord compromise.On (b)(6) 2011: the patient presented with chief complaint of uti.The patient presented with chief complaint of r/o renal calculi.On (b)(6) 2012: the patient underwent radiology examination of hand 3 views, r+l.On (b)(6) 2012: the patient underwent mri of c-spine.Findings: shows a previous fusion from c5 to c7 with reverse lordosis, she had some mild bilateral neuroforaminal stenosis at c5-6.On (b)(6) 2012: the patient presented with neck and right arm pain.Patient underwent physical examination.Neurologic: she was awake, alert and oriented x3 with fluent speech.Her memory appears to be intact to both recent and remote events.On (b)(6) 2012: the patient presented with pain and swelling the patient underwent x-ray of bilateral knees.Findings: extremely tiny patellar osteophytes compatible with minimal degenerative change, otherwise normal, very small patellar osteophytes compatible with mild degenerative change, otherwise, normal.On (b)(6) 2012: the patient presented with pain and underwent chest ap adult 1 view x-ray.Findings: shows prior cervical surgery.Heart size was normal and lungs were clear.The patient presented with stroke and underwent ct head/brain w/o contrast.Impressions: no acute intracranial findings, old left basal ganglia lacunar infarcts.On (b)(6) 2012: the patient presented with left shoulder pain and underwent x-ray of shoulder.Impressions: unremarkable exam.On (b)(6) 2012: the patient presented with cough and fever.The patient underwent x-ray of chest pa and lateral.Impressions: no acute findings.On (b)(6) 2012: the patient presented with cva, dysphagia and underwent modified video swallow examination.On (b)(6) 2012: the patient presented with bilateral leg and arm pain and underwent mri thoracic w/o contrast.Impressions: minor degree of thoracic disc bulging.Otherwise negative study.On (b)(6) 2012: the patient presented for follow up with chief complaint of numbness, tingling and weakness.Ros revealed: neurological: the patient admits to tremors or shaking and balance problems.The patient denies any dizzy spell or blackouts.Psychiatric: the patient admits to feelings of anxiety and hearing voices.The patient denies any feeling depressed.The patient underwent general examination of cervical spine.Impressions: cervicalgia.On (b)(6) 2014: the patient presented with dyspnea and wheezing the patient underwent chest pa and lateral procedure.Impressions: negative for acute findings.

• 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: 5074276
• MDR Text Key: 25768600
• Report Number: 1030489-2015-02336
• 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: 08/17/2015

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
• Device Expiration Date: 06/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110803AAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2015
• Initial Date FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2009
• 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