MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-11-06 for SATELLITE SPINAL SYSTEM 8000214 manufactured by Warsaw Orthopedic Inc..
[731381]
Date of implant: 2007. It was reported that a pt underwent a surgical procedure with implantation of a sphere device. At an unknown time post-op, pt sustained a traumatic fall on some ice. Xrays reportedly revealed that the implant had migrated posteriorly. Patient underwent revision surgery to remove the implant, approx 1 1/2 months post-op. No other patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[7902915]
Device has not been returned to the mfr; therefore, product evaluation is not possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2007-00338 |
| MDR Report Key | 939844 |
| Report Source | 07 |
| Date Received | 2007-11-06 |
| Date of Report | 2007-10-31 |
| Date Mfgr Received | 2007-10-31 |
| Device Manufacturer Date | 2005-10-17 |
| Date Added to Maude | 2007-11-15 |
| 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 | CHRISTINE SCIFERT, M.S. |
| 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 | 2007-11-06 |
| Model Number | NA |
| Catalog Number | 8000214 |
| Lot Number | W05K0561 |
| 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 | 918802 |
| Manufacturer | WARSAW ORTHOPEDIC INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-06 |