MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-06-04 for SATELLITE SPINAL SYSTEM UNK manufactured by Warsaw Orthopedic, Inc..
[846511]
It was reported by a non-medical professional that the pt underwent a three-level tlif at l3-s1 using three 16mm spherical implants. At an unknown time post-op, the pt is reported to have developed "paralysis below the waist, has been unable to walk or stand on her own, has lost bowel and bladder control, and suffers from severe and permanent neurologic impairment. " no medical reports have been submitted to medtronic that verify these claims. Additionally, no medical evidence linking the implantation of the spherical implants and the pt's reported symptoms has been provided to medtronic.
Patient Sequence No: 1, Text Type: D, B5
[8083572]
Neither the device nor films of applicable imaging studies were returned to the mfr for eval. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2008-00254 |
| MDR Report Key | 1057529 |
| Report Source | 04 |
| Date Received | 2008-06-04 |
| Date of Report | 2008-05-06 |
| Date of Event | 2007-04-11 |
| Date Facility Aware | 2007-04-11 |
| Date Mfgr Received | 2008-05-06 |
| Date Added to Maude | 2008-06-13 |
| 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 | 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SATELLITE SPINAL SYSTEM |
| Generic Name | SPHERE |
| Product Code | NVR |
| Date Received | 2008-06-04 |
| 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 |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1026431 |
| Manufacturer | WARSAW ORTHOPEDIC, INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-04 |