MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Migration (4003)

Patient Problems Gastritis (1874); Neuropathy (1983); Pain (1994); Swelling (2091); Burning Sensation (2146); Reaction (2414); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported as per the patient that the patient had lumbar and thoracic pain; and underwent a redo of l3-l4 fusion with more rods, screws and bone morphogenic protein - 2 (bmp2).The surgery was necessary as the fusion done previously had become unstable and a cyst had formed with a screw in situ.The patient had a surgery on (b)(6) 2019 as well because when the patient was walking with the physio, she had pain in her right foot, severe pain over her whole lumbar spine and left buttock, hot extremely swollen back.The nerve pain was excruciating and she was told the bmp2 had leaked onto the nerves.The patient also noticed altered sensation on left side of her back and buttock.She had a lot of pain around the ribs on her left side, which felt neuropathic.Her skin from buttock up to her mid thoracic level felt like severe sunburn.Reportedly, the patient had over 20 spinal operations and she had never experienced nerve pain on so many levels.Allegedly, she had gut discomfort in hospital; however, within three weeks the epigastric pain was becoming unbearable.One month post operatively, she had burning unbearable in stomach, buttocks, back and feet.The patient also reported that all swelling and redness went down within a week, but the burning sensation and altered sensation and neuropathy continued.The patient had many gastrointestinal investigations, which found to have a gallstone in the bile duct, had an ercp which did not change.She had more gallstones in the gallbladder, but gastro consultant said removing gallbladder was not likely to remove pain.She also saw a rheumatologist, who found no autoimmune disease or any other obvious problem.She have had an mri and abdominal mri, which showed the thoracic disk was inflamed but would eventually fuse itself.She had increased the dose of gabapentin.The patient cannot eat anything without an increase in gastric pain.Reportedly, the patient's feet are very painful.She has difficulty walking any distance and her back still feels like it has severe sunburn.Patient's spinal surgeon was unable to determine the cause of the reaction.The patient suspects that the synthetic bone is touching nerve ends (she is a former nurse).So far, she has had many tests done, unfortunately with no results.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9570662
• MDR Text Key: 186587923
• Report Number: 1030489-2020-00044
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/09/2020
• 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): Required Intervention
• Patient Age: 64 YR