MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-10-07 for SATELLITE SPINAL SYSTEM manufactured by Warsaw Orthopedics.
[2284312]
Patient medical records state that the patient diagnosed with l4-5 herniated disc, foraminal stenosis, and left l5 radiculopathy underwent a procedure for left l4-5 microdiscectomy, foraminotomy, and posterior lumbar intervertebral nucleoplasty. Post-op the patient did well and low back pain decreased, but later developed numbness in the left leg and right foot. An mri showed no evidence of canal or foraminal impingement at l4-5 or the previously fused l5-s1 level. Physical examination was positive for sensory impairment of the left lateral leg and foot and distal right foot bottom. Ct and myelogram showed no fusion occurring at l4-5 and an uncertain discrepancy in the density of subarachnoid contrast above the l4-5 disc and below l4-5. Approximately 5 months post-op the patient underwent a second procedure for l4-5 decompression laminectomy and partial l3 laminectomy, followed by posterior lumbar interbody fusion at l4-5 and posterior segmental instrumentation at l4-5. During surgery, it became evident that the posterior elements at l5 had fractured, and the spinous process, as well as the majority of the, lamina bilaterally, were being held by only ligamentous support. Dorsal elements of l5 were removed. Durotomy revealed a constrictive mass that was causing the myelographic block on previous myelogram. Dissection freed all of the nerve roots and emg activity significantly improved. Post-op the patient symptoms improved, but later low back pain increased with tingling in the legs. The patient underwent a third procedure for removal of the initially implanted interbody device and for alif with peek implant. The patient then underwent a fourth procedure for implant of spinal stimulator.
Patient Sequence No: 1, Text Type: D, B5
[9308912]
(b)(4). The device or applicable imaging studies have not been returned to medtronic for evaluation. Unable to determine cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[9379111]
Patient x-rays were received for review. Multiple studies spanning 2006-2010 show interbody fusion at l5-s1 with degenerative disc at l4. Spherical implant placed at l4-5 and eventual pedicle screws at l4-5. Sagittal views show apparent mass in canal from l4-5 to mid-sacrum which is not seen on axial views. Final x-rays show removal of spherical device with new device paced at l4-5.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2011-01297 |
| MDR Report Key | 2283426 |
| Report Source | 00 |
| Date Received | 2011-10-07 |
| Date of Report | 2011-09-09 |
| Date Mfgr Received | 2011-10-20 |
| Date Added to Maude | 2011-10-07 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1030489-092707-008-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SATELLITE SPINAL SYSTEM |
| Generic Name | PROSTHESIS, INTERVERTEBRAL DISC |
| Product Code | NVR |
| Date Received | 2011-10-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-07 |