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 Apnea (1720); Asthma (1726); Chest Pain (1776); Dyspnea (1816); Edema (1820); Fatigue (1849); Nausea (1970); Pain (1994); Pneumonia (2011); Rash (2033); Swelling (2091); Weakness (2145); Sore Throat (2396); 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) 2008: patient presented for the following pre-op diagnosis: l5-s1 spondylosis with spondylolisthesis, with chronic back and extremity pain.Patient underwent following procedure: bilateral far-lateral transfacet transpedicular decompression of the l5 and s1 nerve roots.L5-s1 posterior lumbar interbody fusion.L5-s1 pedicle screw stabilization.Per op-notes- ¿ the posterior elements were entirely removed at the time.Surgeon entered the disk space bilaterally with a 15 blade, curets and kerrisonsxxx and dilated the disk space from about 6 mm up to 10 mm in height, which reduced the spondylolisthesis.Surgeon cleared the disk space thoroughly and filled it with bone morphogenic protein, and impacted bilateral 10 mm x 26 mm cages.These cages also had the patient¿s own morselized posterior elements and bone morphogenic protein placed.Then the c arm was brought in and pedicles were identified with a drill and pedicle finder, and the bilateral l5 and s1 pedicles.These screws were torqued appropriately to break off.Closure was performed with hemostasis, bacitracin irrigation, vicryl in layers, steri-strips in skin, and a clean dry dressing was placed.No patient complications were reported as a result of the event.¿ patient also underwent a physical exam.Impressions: apnea and respiratory insufficiency.Pain.Hypoventilation.Patient also underwent a fluoroscopy exam.Findings: spot image of the lumbar spine was submitted.Bony detail was poor due to intraoperative nature of the film.There was posterior pedicle screw fixation at what appeared to be l5-s1.Intervertebral body disk device appeared grossly satisfactory.Post-op films suggested.On (b)(6) 2008: patient was diagnosed with l5-s1 spondylolisthesis and underwent l5-s1 posterior lumbar interbody fusion with pedicle screw stabilization.Patient suffers from difficulty with sitting or standing for any period of time.Ambulation is painful.On (b)(6) 2009: patient presented with an office visit due to hearing problem and sleep apnea.Patient was diagnosed with persistent nasal congestion, menopause and was referred to an ent.On (b)(6) 2009: patient presented for a follow-up visit due to an irritated seborrheic keratosis in the medial aspect of the left forearm distal at about 14 mm that she keeps scraping off.On (b)(6) 2010: patient presented with an office visit due to pain in the lower leg.Patient also underwent a radiology exam of pa and lateral chest.Impressions: normal chest.On (b)(6) 2010: patient presented for a follow-up visit due to pneumonia.Patient was bitten by spider and suffers pain.Patient was diagnosed with sleep apnea.On (b)(6) 2011: patient presented for an office visit due to hypothyroidism.On (b)(6) 2011: patient presented for an office visit due to swollen legs and sore throat.On (b)(6) 2011: patient presented with complaint of fatigue and thyroid problems.Patient underwent a review of systems which revealed general malaise and fatigue.On (b)(6) 2011: patient presented for a follow-up visit due to rash.Patient underwent following diagnosis: punch biopsy of skin (right forearm) with a subcorneal/ intraepidermal pustular dermatitis and underlying perivascular and interstitial mixed cell infiltrate and dermatofibroma (skin, left shin).On (b)(6) 2011: patient presented for a follow-up visit of right forearm, sub-conceal intraepidermal pustular dermatitis and underlying perivascular and interstitial mixed ill-infiltrate.On (b)(6) 2011: patient presented with a ct exam of chest without contrast due to dyspnea.Impressions: no evidence of interstitial lung disease.No acute abnormality within the lungs.Patient also underwent an x-ray exam due to dyspnea.Findings: no spontaneous or elicited gastro- esophageal reflux was identified during examination.On (b)(6) 2011: patient presented with an office visit due to lung pain on inspiration, periods of bradycardia, fingers stiff, swelling, nausea, knee pain and body pain.On (b)(6) 2011: patient presented with a chief complaint of fatigue, thyroid problems and dyspnea.Constitutional review of systems revealed general malaise and fatigue.On (b)(6) 2011: patient was diagnosed with moderately dense infiltrate of predominantly neutrophils with edema of the papillary dermis of the skin(left shin).On (b)(6) 2011: patient presented for a office visit for evaluation of shortness of breath.Patient also underwent an x-ray.Assessment: shortness of breath.Snoring with hypersomnia consistent with obstructive sleep apnea syndrome.Obesity.On (b)(6) 2011: patient underwent a polysomnogram study.Impressions: mil-to-moderate obstructive sleep apnea with hypersomnia.Possible superimposed periodic leg movement disorder with arousals noted.Poor sleep efficiency.On (b)(6) 2011: patient presented with a ct scan of chest without contrast which revealed a mild scattered bronchial wall thickening consistent with large airways inflammatory disease.Mild dependent edema in the posterior lungs which does not persist on prone images.On (b)(6) 2011: patient presented for an office visit.Assessment: extrinsic asthma.Mild to moderate obstructive sleep apnea and shortness of breath.On (b)(6) 2011: patient presented with follow-up visit of extrinsic asthma, sleep apnea and shortness of breath.On (b)(6) 2011: patient presented with a follow-up visit due to fatigue, thyroid problems and dyspnea.Patient still suffered from dyspnea.On (b)(6) 2011: patient presented with an office visit due to painful breathing, diffuse joint pains, fatigue, difficult concentration and multiple episodes of anaphylaxis, allergic reactions to many substances.On (b)(6) 2011: patient presented with a follow-up visit.Impressions: history of photosensitive rash, episodes of flushing, nail dystrophy.Patient also underwent a bilateral digital screening breast exam.Findings: no significant findings.On (b)(6) 2011: patient presented with an office visit with varicose veins, left lower extremity.Diagnosis: left lower extremity varicose veins with incompetent great saphenous vein.On (b)(6) 2011: patient presented for an office visit due to asthma.On (b)(6) 2011: patient made a triage phone call due to dyspnea.On (b)(6) 2011: patient called due to dyspnea on exertion, asthma, large sighs and reduced total igg level.On (b)(6) 2012: patient presented for a follow-up visit due to solar urticaria.On (b)(6) 2012: patient presented with a follow-up visit due to autoimmune disorder, fatigue and post nephrology and dermatology tests.Patent underwent a musculoskeletal review of system which revealed swelling, pain and abnormal joints.Constitutional review of systems revealed fatigue and significant nutritional problems.On (b)(6) 2012: patient presented for a follow-up visit due to fatigue, autoimmune disorder, thyroid problems and dyspnea.Patent underwent a musculoskeletal review of system which revealed swelling, pain and abnormal joints.Constitutional review of systems revealed fatigue and significant nutritional problems.On (b)(6) 2012: patient presented for a follow-up visit due to urticaria.On (b)(6) 2012: patient presented for a follow-up visit due to urticaria due to asthma getting worse.On (b)(6) 2012: patient presented for a follow-up visit due to urticaria.On (b)(6) 2012: patient presented with extrinsic asthma, mild to moderate (severe supine position), obstructive sleep apnea and shortness of breath to an office visit.On (b)(6) 2013: patient presented for a follow-up visit due to urticaria.Patient suffered from weakness and episodes of being unable to move extremities, sleep and not feeling well.

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: 5698122
• MDR Text Key: 46563993
• Report Number: 1030489-2016-01618
• 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
• Report Date: 05/05/2016

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 Expiration Date: 01/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110706AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: 05/05/2016
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2008
• 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: 114