MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-01-22 for SATELLITE SPINAL SYSTEM UNK manufactured by Warsaw Orthopedic Inc..
[16170485]
It was reported by a non medical professional that the patient underwent a fusion procedure at l5-s1 in 2005. The surgeon performed a lumbar laminectomy with medical facetectomies and foraminotomies, for complete decompression of the dural and neural elements and transforaminal interbody fusion. An interbody fusion stabilization device was used at l5-s1. At an unknown time post-op, the patient experienced severe back pain and other symptoms. In early 2007, the surgeon performed an additional operation on the patient at l5-s1 to install pedicle screw instrumentation. After this second surgery, the patient continues to have severe symptoms, including loss of sensation, difficulty in walking, and difficulty sleeping.
Patient Sequence No: 1, Text Type: D, B5
[16203307]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2009-00077 |
| MDR Report Key | 1297543 |
| Report Source | 00 |
| Date Received | 2009-01-22 |
| Date of Report | 2008-12-31 |
| Date of Event | 2007-01-08 |
| Date Mfgr Received | 2008-12-29 |
| Date Added to Maude | 2009-02-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDIC INC. |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46852 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46852 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SATELLITE SPINAL SYSTEM |
| Generic Name | SPHERE |
| Product Code | NVR |
| Date Received | 2009-01-22 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDIC INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US 46852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-22 |