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 Dyspnea (1816); Weakness (2145); Discomfort (2330); Injury (2348)

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) 2009 the patient underwent mri of lumbosacral spine.There was a mild bulge centrally of the l5-s1 disc but no definite impingement on nerve roots was evident.No other disc herniation: no spinal stenosis.There was normal alignment of lumbosacral spine.No compression fractures or other bony abnormalities.No appreciable arthritic changes.On (b)(6) 2009 the patient presented with back pain.Plain film x-rays showed really no significant abnormality.His mri scan showed complex annular tear at l5-s1 with disc desiccation, perhaps some modic endplate changes adjacent.Impression: discogenic back pain.On (b)(6) 2009 the patient underwent fluoroscopic guided l3-l4, l4-l5 and l5-s1 discograms.Impression: concordant painful l5-s1 discogram and a moderately degenerated l5-s1 disc.The patient also underwent ct of lumbar spine due to back and bilateral leg pain.Impression: dorsal midline annular tear with mild diffuse disc bulge at l5-s1 without spinal stenosis or nerve root impingement.On (b)(6) 2009 the patient presented for an office visit.Review of systems: his back pain was getting a little bit worse lately.He was taking his pain medications as scheduled.He had no other acute problems.He had some psychiatric issues in the past which has since resolved.He had dependence to benzodiazepines which he was completely off now.Otherwise, he had been doing fairly well.He had no other neurologic or psychiatric problems at time, outside of those mentioned above.He had no history of cardiopulmonary problems or gastrointestinal problems.The patient underwent following tests: ekg: normal sinus rhythm without any acute st or t-wave changes.Chest x-ray: shows no acute cardiopulmonary process, negative exam.Impression: this (b)(6) gentleman with minimal risk for perioperative complications (b)(6) 2009 the patient presented with chronic back pain.The patient underwent the following procedures: anterior lumbar interbody fusion l5-s1 with femoral ring allograft and rhbmp-2/acs bone morphogenetic protein; posterior spinal fusion with abbott lab pathfinder device pedicle screws; anterior exposure l5-s1; placement of pain pump.Per op notes: once the exposure was adequate at l5-s 1, a radiographic marker was placed to verify the operative level and a complete diskectomy was then performed using a sharp annulotomy and various sizes of pituitary forceps and curets to prepare the end space.A 12 and then a 14 mm rasp was used to prepare the end plates and a 14 mm allograft of bone packed with rhbmp-2/acs bone morphogenetic protein was placed into the disk space using the catalyst device.Prior to surgery, he had a diskogram with ct.He had concordant pain at l5-s1.He had a mri which showed an annular tear at l5-s1 with disk desiccation and modic endplate changes.He had an x-ray of the lumbar spine.No complications identified.On (b)(6) 2009 the patient was discharged.On (b)(6) 2009 the patient had a telephonic conversation regarding his medication not working.On (b)(6) 2009 the patient called regarding back discomfort and weakness.He also stated he was short of breath.On (b)(6) 2009 the patient presented for a follow up.His x-rays showed excellent position of implanted devices.On (b)(6) 2009 the patient presented for a follow up.He was doing pretty well.On (b)(6) 2009 the patient presented for a follow up.He complained of some lower back discomfort.He had some muscle tension and tightness around the left paraspinal muscles.

• 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: 5159905
• MDR Text Key: 28673467
• Report Number: 1030489-2015-02736
• 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: 09/21/2015

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 Catalogue Number: 7510200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• 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