MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-01-23 for SATELLITE SPINAL SYSTEM manufactured by Warsaw Orthopedics.
[2494890]
A ct and myelogram done on (b)(6) 2011 showed a failed interbody fusion at l4-5, and narrowing of the l5-s1 disc.
Patient Sequence No: 1, Text Type: D, B5
[2511876]
It was reported by the patient's attorney that the patient was pre-operatively experiencing recurring lower back pain and pain-producing degenerative changes. The patient underwent posterior spinal surgery in which a spherical interbody device was implanted at the l4-5 level. Reportedly the patient developed neurological injuries post-op and later underwent another procedure for removal of the device. The patient currently receives pain management treatment.
Patient Sequence No: 1, Text Type: D, B5
[9546086]
(b)(4). The device or applicable imaging studies were not provided to the manufacturer for evaluation. We are unable to determine cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[9654526]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2012-00075 |
| MDR Report Key | 2424953 |
| Report Source | 00 |
| Date Received | 2012-01-23 |
| Date of Report | 2011-12-27 |
| Date Mfgr Received | 2012-02-14 |
| Date Added to Maude | 2012-01-23 |
| 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 | 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 | 2012-01-23 |
| 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 | 2012-01-23 |