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 Apnea (1720); Arthritis (1723); Chest Pain (1776); Hyperplasia (1906); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Vertigo (2134); Weakness (2145); Cramp(s) (2193); Dizziness (2194); Myalgia (2238); Stenosis (2263); Sinus Perforation (2277); Pressure Sores (2326); Arthralgia (2355); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent a lumbar fusion procedure at l5 to s1 using rhbmp-2/acs.Post-operatively, patient continues to experience severe and unrelenting low back pain and radiculopathy into his bilateral lower extremities.This pain precludes him from sitting or standing for long periods of time.His legs give out beneath him, making it difficult and dangerous to ambulate.Furthermore, following his surgery, patient suffers from sexual dysfunction including erectile dysfunction and retrograde ejaculation.

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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2009: the patient presented with degenerative disc disease at l5-s1 and underwent the following procedures: trans-abdominal approach to l5-s1 disk space.L5-s1 complete discectomy ¿ anterior approach.Insertion of cage 14mm 5 degree with medium bone morphogenic protein in the cage.A 45mm sacral plate with 22mm screws times four.As per-op notes, ¿¿l5-s1 disk space was exposed, incision done.Complete discectomy was done at l5-s1 level.Additional disk was removed.A small 14mm 5 degree cage had been filled with a medium package of bone morphogenic protein sponge, tapped in place, found to be firmly seated and appropriately counter sunk.It was then fixated with a 45mm sacral plate and 22mm screws times four.The screws were tightened.Anterior posterior lateral radiography verified appropriate positioning¿¿ no patient complication was reported.On (b)(6) 2009: the patient presented for an office visit.The patient still had problems with erectile dysfunction.The patient underwent x-ray of anterior posterior and lateral lumbar spine.On (b)(6) 2009: the patient underwent mri of lumbar spine due to post laminectomy syndrome.Summary: stable findings.Tiny rounded focal lesion in the cauda equine at l2 is unchanged.Right lateral small focal disc change at l3-l4 in the foramen is questionable.The appearance is unchanged.On (b)(6) 2012, (b)(6) 2013: the patient presented for an office visit.On (b)(6) 2013: the patient underwent mri of lumbar spine due to increasing lower extremity pain and paresthesias, spinal canal stenosis, lumbar surgery and lumbar fusion.Summary: facet arthritis and mild spondylolisthesis associated with mild spinal canal narrowing at l4-l5.No change.Post-operative changes at l5-s1.There is no evidence of recurrent disc herniation.11 mar 2013: the patient presented for a routine visit.On (b)(6) 2013: the patient presented for routine visit with problems of benign neoplasm of spinal cord, type ii diabetes mellitus, mixed hyperlipidemia, other and unspecified hyperlipidemia, essential hypertension benign, acute sinusitis, hypertrophy, impotence of organic origin, osteoarthritis, lumbago, sciatica.On (b)(6) 2014: the patient presented for check-up with problems of benign prostatic hyperplasia, benign neoplasm of spinal cord, type ii diabetes mellitus, mixed hyperlipidemia, overweight, benign paroxysmal positional vertigo, benign essential hypertension, acute sinusitis, nasal discharge, impotence of organic origin, osteoarthritis, low back pain, sciatica.On (b)(6) 2014: the patient presented for an office visit with dizziness.On (b)(6) 2014: the patient underwent the following test: ¿nm lexi stress¿ due to abnormal electrocardiogram.Impression: no definite ischemia or infarct.Normal left ventricular ejection fraction measuring > 70%.On (b)(6) 2014: the patient presented for an office visit.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2009: patient presented for postoperative follow visit.On (b)(6) 2009: the patient underwent radiographic study of lumbar spine.Impression: post-surgical changes at l5-s1.Patient reports some tightness in calves.On (b)(6) 2009: patient called and complained of new erectile dysfunction symptoms since surgery.On (b)(6) 2009: patient presented for office for physical therapy (initial evaluation).Patient currently reports pain in both lower extremities posteriorly all the way down both legs with pain also on the lateral and medial aspects of the legs.Patient is lightly tender in the bilateral lower paraspinals and also slightly tender in sij area and gluteal bilaterally.Assessment: his spinal range of motion is fair and lower extremity strength is significantly weak on the left more than on the right.On (b)(6) 2009: patient was discharged from physical therapy.Patient does report soreness in both calves with right greater than left.On (b)(6) 2009: the patient underwent radiographic study of lumbar spine.Impression: status post fixation at the l5-s1 level without a significant change in alignment.Patient reports occasional cramping in lower legs.On (b)(6) 2009: patient underwent radiographs of lumbar spine(ap and lat) status post lumbar surgery.Impression: interval anterior spinal fusion procedure at l5-s1.Mild degenerative disease from t9-t10 through t12-l1.On (b)(6) 2009: the patient underwent bone radiographic length assessment due to back pain, leg length discrepancy.Patient has some increased pain with standing.Hamstrings are tight.Patient underwent radiological test (ap-lat) of lumbar spine.On (b)(6) 2009: the patient underwent radiographic study of lumbar spine.Impression: post-surgical changes at l5-s1.On (b)(6) 2009: the patient underwent anterior-posterior and lateral study of lumbar spine.Impression: stable appearance of the anterior inter-body fusion at l5-s1.Minimal anterolisthesis of l4 upon l5, stable.On (b)(6) 2009: the patient underwent radiographic study of lumbar spine.Impression: status post fixation at the l5-s1 level without a significant change in alignment.On (b)(6) 2009: the patient underwent bone radiographic length assessment due to back pain, leg length discrepancy (b)(6) 2014: the patient presented for an office visit with chief complaints of instability and pain.The patient was diagnosed with pain in lower leg joint and muscle weakness.On (b)(6) 2013: patient presented for a routine visit.Assessment: acute sinusitis; benign neoplasm of spinal chord.On (b)(6) 2015: patient presented for possible obstructive sleep apnea because of problems maintaining sleep.Impression: mild obstructive sleep apnea.On (b)(6) 2015: patient presented for a routine visit with diabetes, hyperlipidemia, and hypertension.Assessment: pain; benign essential hypertension; hyperlipidemia; obstructive sleep apnea syndrome; type 2 diabetes mellitus without complication; allergy; weakness of limb; gastroesophageal reflux disease; no diagnosis.On (b)(6) 2014: patient underwent lexi stress test with perfuse due to indication of abnormal electrocardiogram.Impression: no definite ischemia.Normal left ventricular ejection fraction measuring > 70%.On (b)(6) 2014: patient presented for follow up.Assessment: atypical chest pain; type 2 diabetes mellitus without complication; hyperlipidemia; benign paroxysmal positional vertigo; strain of knee.On (b)(6) 2015, (b)(6) 2016: patient presented with complaint of diabetes; hyperlipidemia; hypertension.Assessment: type 2 diabetes mellitus without complication; mixed hyperlipidemia; primary hypertension; obstructive sleep apnea; prostate cancer screening.On (b)(6) 2016: patient presented with complaint of musculoskeletal pain.Assessment: myalgia, arthralgia, cervicalgia.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4189226
• MDR Text Key: 20750747
• Report Number: 1030489-2014-04092
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• 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: 7510400
• Device Lot Number: M110707AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2008
• 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: 88