MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-10-16 for SATELLITE SPINAL SYSTEM 8000211 manufactured by Medtronic Sofamor Danek Manufacturing.
[972672]
It was reported that the interbody device was explanted due to post op pain. It was also found that the device was subsided. The implant level was at l5-s1. No other patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[8213725]
Neither device nor film of applicable imaging studies were returned to the manufacturer for evaluation. Device history records were reviewed. No documentation was found that would indicate a non-conformance to specifications. Unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2008-00579 |
| MDR Report Key | 1209055 |
| Report Source | 07 |
| Date Received | 2008-10-16 |
| Date of Report | 2008-09-22 |
| Date of Event | 2008-08-28 |
| Date Mfgr Received | 2008-09-22 |
| Device Manufacturer Date | 2005-10-17 |
| Date Added to Maude | 2008-10-28 |
| 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 | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK MANUFACTURING |
| 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 | 2008-10-16 |
| Model Number | NA |
| Catalog Number | 8000211 |
| Lot Number | W05K0567 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1257117 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK MANUFACTURING |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-16 |