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 Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Loss of Range of Motion (2032); Tinnitus (2103); Urinary Tract Infection (2120); Sinus Perforation (2277); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.

Event Description

It was reported that on: (b)(6) 2004: the patient was admitted with the following pre-operative diagnosis: l5-s1 spondylolisthesis.Lumbar radiculopathy.He underwent the following procedures: l5-s1 transforaminal lumbar interbody fusion with allograft, instrumentation and rh-bmp2/acs.Right l5-s1 decompression.Right l5-s1 laminotomy and foraminotomy.Other implants, which were used in the surgery, were: tissue trace allograft; pedicle screws and rods.Per op notes, complete facetectomy was performed at the left l5-s1 facette joint.This allowed exposure of the left posterior side of the disc space.Epidural veins were coagulated and the disc space was identified.The exiting nerve root was identified and protected with a nerve root retractor.The superior and inferior end plate at this location was taken down using osteotome.A 9 mm allograft, kidney bean shaped, interbody spacer was placed in the posterior aspect of the disc space.Prior to its placement a medium rh-bmp2/acs with four sheets of collagen sponge were wrapped around graft, and placed in the anterior aspect of the disc space.Then the allograft was placed.A rod was then placed on the left side and used to compress the graft.This was found to be very secure after compression with the screws.Decompression was then performed on the right side at l5-s1 with elevation of the ligamentum flavum and a foraminotomy, to ensure that the right l5 nerve root was well decompressed.The wound was irrigated with copious amounts of normal saline prior to placement of any graft material and once again after all hardware was in place and secured and all screws were given a final tightening.No patient complications were reported.(b)(6) 2004: the patient was discharged with the following diagnosis: status post l5-s1 trans foraminal lumbar interbody fusion for l5-s1 spondylolisthesis with radiculopathy.(b)(6) 2006: the patient presented with low back pain due to heavy load lifting.Pain was mostly on the left side of the back and also in the left hip.(b)(6) 2006, (b)(6) 2006: the patient presented with worsening back pain and some discomfort in the right upper buttock region.Prolonged standing made the pain worse.Musculoskeletal examination revealed diffuse tenderness in the paraspinal muscle groups.(b)(6) 2007: the patient presented for follow-up with some discomfort in his right lower back that made its way to his right lower extremity at times.Musculoskeletal examination revealed diffuse paraspinal tenderness in the lower lumbosacral area, specifically on the right side.(b)(6) 2007: the patient underwent right upper quadrant sonogram due to elevated liver function tests.Impression:diffuse fatty infiltration of the liver; no other significant findings.(b)(6) 2007: the patient presented for follow-up with elevation in his blood pressure.Assessment: diabetes mellitus type 2.Hypertension.Degenerative disk disease of the back.Fatty infiltration of the liver.(b)(6) 2007, (b)(6) 2008: the patient presented for follow-up.Assessment: diabetes mellitus, type 2.Hyperlipidemia.Hypertension.History of fatty infiltration of the liver.(b)(6) 2009, (b)(6) 2010, (b)(6) 2011: the patient presented for follow-up.His sinuses had been bothering him for the last week or so, drainage in the back of his throat, feverishness, chilliness.Headache frontal in nature had also been reported.Mild cough and minimal sputum production was reported.Assessment: diabetes mellitus, type 2.Hyperlipidemia.Hypertension.Sinusitis.Degenerative disk disease of the spine.(b)(6) 2009: the patient presented with uncontrolled diabetes.Assessment: obesity.(b)(6) 2010: the patient presented with right shoulder pain, status post labral debridement.(b)(6) 2010: the patient presented with problems in right bicep after he fell off from his truck.He sustained a calcaneus fracture and a proximal humerus fracture.He sustained injury to his "calcaheus" on the left and then his right shoulder injury.He underwent mri which demonstrated a proximal biceps rupture.Assessment: long head biceps rupture, right shoulder.(b)(6) 2010: the patient presented with following pre-op diagnosis: right shoulder biceps tendon rupture.The patient underwent the following procedures: right shoulder arthroscopy, debridement of superior labral tear.Biceps tendon tenodesis.No patient complications were reported.(b)(6) 2010, (b)(6) 2011: the patient presented for follow-up for his shoulder scope and biceps tenodesis, "laberal" debridement.He complained of a little numbness and tingling in his thumb, reproduced by tapping over his brachial plexus.(b)(6) 2010: the patient presented for physical therapy.He continued to demonstrates limitations in right shoulder range or motion.(b)(6) 2011: the patient presented for follow-up for his shoulder scope and biceps tenodesis.(b)(6) 2011, (b)(6) 2012: the patient presented for an office visit with diabetes mellitus, hypertension and hyperlipidemia.Assessment: prostate cancer screening; diabetes mellitus; hypertension; hyperlipidemia; left ear pain.(b)(6) 2012: the patient presented for an office visit with diabetes mellitus.The patient had minimal pain.(b)(6) 2012: the patient presented with tinnitus.(b)(6) 2012: the patient had audiogram test, which revealed normal hearing in both the ears.(b)(6) 2012: the patient presented with hematuria, dysuria and right flank pain.Assessment: urinary tract infection.(b)(6) 2013: the patient presented with diabetes mellitus type 2, hypertension and chronic back pain.

• 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: 5044151
• MDR Text Key: 24656737
• Report Number: 1030489-2015-02134
• 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

• Date FDA Received: 09/01/2015
• 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: M112003AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• 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: 97