MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-02-27 for SATELLITE SPINAL SYSTEM 8000213 manufactured by Warsaw Orthopedic Inc..
[20239415]
It was reported that an implanted sphere devices was explanted.
Patient Sequence No: 1, Text Type: D, B5
[20401746]
Neither device nor film of applicable imaging studies were returned to the mfr for evaluation. We are unable to determine the cause of the event. Device history records were reviewed. No documentation was found that would indicate a non-conformance to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2009-00216 |
| MDR Report Key | 1327953 |
| Report Source | 07 |
| Date Received | 2009-02-27 |
| Date of Report | 2009-02-05 |
| Date Mfgr Received | 2009-02-05 |
| Device Manufacturer Date | 2005-10-17 |
| Date Added to Maude | 2009-03-05 |
| 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 | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9019363133 |
| 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 | 2009-02-27 |
| Model Number | NA |
| Catalog Number | 8000213 |
| Lot Number | W05K0557 |
| 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 | 2009-02-27 |