MAUDE Adverse Event Report: WARSAW ORTHOPEDICS INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510800

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

Patient Problems High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Pain (1994); Tinnitus (2103); Hernia (2240); Sore Throat (2396); Respiratory Tract Infection (2420)

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 with complaints of back pain and leg numbness.Patient underwent sinus rhythm with first degree.On 25 mar 2008 patient presented with admission diagnosis of: degenerative disc disease, lumbar stenosis, hypertension, and reflux.Procedure performed: 1.L3-4 anterior lumbar discectomy, 2.L4-5 anterior lumbar discectomy.3.L4 anterior lumbar arthrodesis.4.L4-5 anterior lumbar arthrodesis.5.Anterior lumbar interbody device at l3-4.6.New invasive 55 x 10 mm cage at l4-5 lordotic 8mm x 55 mm cage.Impression: back and leg pain with lumbar stenosis.Per-op notes: the cannula and the k-wire were removed.Nerve stimulator was utilized to stimulate the areas circumferentially.No obvious nerve root irritation was noted.Then placed in a 15 blade.The disc contents were utilized a pituitary and curets.The end plate was prepared for the arthrodesis.A 55 x 10 mm cage was selected and tried.The cage was then packed with bone morphogenic protein and placed under fluoroscopic.Other implants used: cage 18 x 55- 8 mm, cage 18 x 55 - 10 mm.On 27 mar 2008 patient discharged.On (b)(6) 2008, (b)(6) 2008, (b)(6) 2008 patient went for follow-up visit.Patient diagnosed for x-rays.Impressions: status post xlif l3-$, l4-5.The patient is doing excellent.On (b)(6) 2008 patient examined for dx/spine lumbar.Findings: there are advanced degenerative changes.Again seen are interbody spacers at l3-l4 and l4-l5.These appear unchanged from the prior study.Alignment is appropriate.On (b)(6) 2008 patient presented with follow-up hypercholesterol, chronic back pain.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.On (b)(6) 2008 patient underwent the injection procedure.Patient presented with sinus infection/strep throat.(b)(6) 2008 patient presented with back pain, follow-up for back surgery.On (b)(6) 2008 patient presented for follow-up and labs for cholesterol.Assessment: new problems pharyngitis acute, sinusitis.On (b)(6) 2008 patient presented with immunizations.On (b)(6) 2009 patient examined.Impressions: status post l3-4 and 4-5 anterior lumbar fusion.On (b)(6) 2009 patient underwent mammo bilat screening.Impressions: stable, no mammographic evidence of malignancy.On (b)(6) 2009, (b)(6) 2009, (b)(6) 2009, (b)(6) 2009 patient presented with flu labs anemia, gerd, anemia, gastric banding hx, hoarseness, and floaters.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.On (b)(6) 2010 patient underwent mammogram bilat screening.Impression: 1.Stable, no mammographic evidence of malignancy.2.Bi-rads 1, negative, routine annual screening recommended.On (b)(6) 2010 patient presented with back pain.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.Diffuse bilateral weakness- 4/5 dorsiflexion and hip flexion.On (b)(6) 2010 patient presented with back pain.On (b)(6) 2010 patient presented with ble, tonail dystrophy.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.On (b)(6) 2010 patient presented with chief complaint of sore throat.Review of musculoskeletal system, denies neck pain, back pain, radicular nerve pain, joint pain, and joint stiffness.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact.On (b)(6) 2010 patient presented with chief complaint of elevated bs per cardiologist.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.On (b)(6) 2010 patient presented with hereto follow-up on her blood sugars.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.On (b)(6) 2010, (b)(6) 2011 patient presented with chief complaint of cold and uri symptoms.Review of musculoskeletal system, patient reveled complaints of joint pain, joint stiffness, bilateral knees.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.On (b)(6) 2010, (b)(6) 2012 patient presented with immunizations, dm, hyperlipid, and tinnitus.Review of neurology system, patient reveled cn ii-xii grossly intact, peripheral exam nonfocal, strength intact.Gross sensation intact, station <(>&<)> gait normal.Assessment: new problem of postmenopausal bleeding.On (b)(6) 2011 patient presented with htn hyperlipid.Assessment: new problems: mixed hyperlipidemia, dm.On (b)(6) 2011 patient underwent mammogram bilat screening.Impression: bi-rads 2: benign findings.Routine mammographic follow-up in one year recommended.On (b)(6) 2012 patient presented with ventral hernia, sob.Joint pain htn pelvic pain.Review of musculoskeletal system, patient reveled complaints of joint stiffness, joint swelling.On (b)(6) 2012 patient presented with congestion coughing, sinus achy, myalgias in right hip and right shoulder.Assessment: new problem: uri.Review of musculoskeletal system, patient reveled complaints of tender points, myalgias, right hip and shoulder.On (b)(6) 2013 patient presented with possible kidney infection.Assessment: back strain lumbar, muscle spasm, flank pain.On (b)(6) 2013 patient presented with shoulder and back pain.On (b)(6) 2013 patient presented with throat problem.Assessment: gerd- deteriorated, chronic laryngitis- due to gerd.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• 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: 5045484
• MDR Text Key: 24760482
• Report Number: 1030489-2015-02148
• 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
• Report Date: 08/03/2015

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: 04/01/2010
• Device Catalogue Number: 7510800
• Device Lot Number: M110610AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2007
• 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: 136