MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-12 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[126922345]
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
[126922346]
On (b)(6) 2008: the patient presented for an mri of the lumbar spine with and without contrast scan. Impressions: right hemilaminectomy and discectomy with recurrent disc herniation in the right lateral recess at l5-s1. There is enhancement of the recurrent disc and scar formation in the right lateral recess and right epidural space. Intra and extraforaminal focal disc herniation at the l4-l5 level with likely neuritis of the exiting left nerve rootlet. Minimal transverse narrowing of the posterior thecal sac at l3-l4 due to facet hypertrophy. On (b)(6) 2017: patient presented for office visit with low back and right lower extremity pain. Review of systems: musculoskeletal systems: complains of blurring and photophobia. Patient underwent radiological imaging. Impressions: bilateral upper limbs. Lower back pain. Radiculopathy. On (b)(6) 2017: patient presented for office visit. Patient underwent ct scan of lumbar spine without contrast. Impression: facet changes with vacuum facet on right at l4-5 with some tissue in left lateral position suggesting broad based disc and or scar causing left neural foramina narrowing. On (b)(6) 2017: patient presented for office visit. Review of systems: musculoskeletal systems: complains of fatigue and back pain. Patient underwent radiological imaging. Impressions: bilateral upper limbs. Lower back pain. Radiculopathy. On (b)(6) 2017: the patient presented with the following pre-op diagnosis: lumbar degenerative disc disease, degenerative joint disease, stenosis, radiculopathy. Patient underwent following procedures: right l4-5 and l5-s1 transforaminal lumbar interbody fusion with far lateral transpedicular decompression of exciting and traversing nerve roots, pedicle screw instrumented fusion from l4 to s1, posterolateral fusion from l4 to s1. As per-op notes:? Bony elements from l4 to s1 were decorticated and morselized with local autograft and allograft and placed down laterally as well as some bmp to perform posterolateral fusion from l4 to s1.? No intra-operative complications were reported. On (b)(6) 2018: patient presented for office visit. Review of systems: musculoskeletal systems: leg and back pain. On (b)(6) 2018: patient presented for office visit with complaint of right lateral thigh discomfort. Review of systems: musculoskeletal systems: complains of sciatica. Impression: radiculopathy. Disc degeneration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-01465 |
| MDR Report Key | 8058788 |
| Report Source | CONSUMER |
| Date Received | 2018-11-12 |
| Date of Report | 2018-12-12 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-11-12 |
| 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 | 2018-11-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2018-11-12 |