MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-09 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[186587923]
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.
Patient Sequence No: 1, Text Type: N, H10
[186587924]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00044 |
| MDR Report Key | 9570662 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NEK |
| Date Received | 2020-01-09 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |