MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2015-01-15 for SATELLITE SPINAL SYSTEM UNKNOWN manufactured by Warsaw Orthopedics.
[18034357]
It was reported by lindley et al in a literature publication titled? Failure of the fernstrom ball in contemporary spine surgery: a case of history repeating itself? That: a (b)(6) female patient presented to the clinic with chief complaint of increasing low-back and radicular pain. She had a history of low-back and right leg pain attributed to a disc herniation with foraminal stenosis at the l5-s1 level. She had been treated at an outside institution 15mo earlier with an l5-s1 microdiscectomy, right-sided foraminotomy, and placement of a cobalt chrome ball interbody device. The patient had refused fusion and therefore they decided on placement of the cobalt chrome interbody device to prevent further foraminal stenosis and disc collapse. The patient reported that she had approximately 3mo of pain relief after the surgery with subsequent increased low back pain as well as posterior leg pain with occasional numbness. New radiographs taken at our institution showed a stable, nondisplaced cobalt chrome ball at l5-s1 and a disc herniation at l4-l5 with significant bilateral facet hypertrophy and grade 1 spondylolisthesis. There was no change in the position of the cobalt chrome device between the neutral, flexion, or extension views. The patient returned 4mo later, and a ct scan showed that the cobalt chrome device had begun to migrate posteriorly and was protruding into the canal. At that time, surgical intervention was discussed, but the patient elected to continue with conservative treatment. The patient then returned 7mo later for further evaluation because of similar complaints of increased low-back and leg pain. Repeat radiographs showed that the cobalt chrome ball had migrated out of the l5-s1 disc space into the canal. This resulted in severe loss of disc space height at l5-s1. The spondylolisthesis at l4-l5 also was noted to have worsened. The patient was advised towards removal of the displaced cobalt chrome ball, but she remained reluctant to undergo surgery again and decided to continue on a conservative route. Two years later (approximately 4 y after the original surgery) the patient? S pain had become so debilitating that she finally opted for surgical treatment. At that time she was ambulating with a cane and a kyphotic posture secondary to her pain. A lumbar ct scan showed that the displaced device was residing within the right lateral recess at s1, along the course of the right s1 nerve root. The ct scan also showed increased anterior subluxation of l4-l5. Anterior fusion of l4-l5 and l5-s1 was performed with femoral ring allograft cages and anterior plate fixation. A posterior approach was then performed for revision laminectomy of l5 with partial revision laminectomy of s1. Extensive scarring was evident over the posterior and lateral aspects of the cobalt chrome ball, which was lying under the origin of the right s1 nerve root in the epidural space. The nerve root was carefully retracted to expose and remove the intact cobalt chrome device. After further decompression of the spinal canal and nerve roots with partial medial facetectomies and foraminotomies of l5-s1, pedicle screws were then placed at l4, l5, and s1. At 3mo after revision surgery, the patient reported improvement in her symptoms and was able to ambulate without a cane.
Patient Sequence No: 1, Text Type: D, B5
[18314543]
(b)(4): the device was not returned to the manufacturer for evaluation. X-ray review: lateral x-rays are shown of poor quality. The metallic ball within the l5 disc space is centered on the first film although there is endplate indentation and subsidence noted in all three films. A grade one spondylolisthesis is also seen at l4. Over time a ct reconstruction view shows gradually retropulsion of the device from the disc space. Sclerotic/lytic changes are noted both above and below the ball suggesting a symmetric and destructive loading above and below the device. Upon further time, 7 months postop the device had completely dislocated from the disc space and is sitting in the spinal canal posterior to s1. The l5 disc space has collapsed. Ct shows the ball eccentric to the right and compressing the right s1 root. Surgical interoperative photographs show the device measuring about a centimeter in diameter being removed. Final construct was an alif with anterior quad plate and 4 screws with biological interbody graft and pedicle screws with interbody graft spanning l4 to l5 to s1.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-00150 |
| MDR Report Key | 4421584 |
| Report Source | 03 |
| Date Received | 2015-01-15 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-12-16 |
| Date Added to Maude | 2015-01-15 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2015-01-15 |
| Model Number | NA |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-01-15 |