MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2008-12-04 for SATELLITE SPINAL SYSTEM UNK manufactured by Sofamor Danek Deggendorf Gmbh.
[15631286]
It was reported by a patient that he had undergone a spinal procedure and was implanted an interbody device in 2007. The patient stated that he had the multiple post op complications such as renal issues, leg swelling, and severe leg pain after the procedure. The device was removed approximately four month post op in three months later.
Patient Sequence No: 1, Text Type: D, B5
[15889857]
Neither device nor film of applicable imaging studies were returned to the manufacturer for evaluation. Unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[49243020]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[49243021]
As an additional information, it was reported by the patient that he couldn't walk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2008-00657 |
| MDR Report Key | 1259228 |
| Report Source | 00,OTHER |
| Date Received | 2008-12-04 |
| Date of Report | 2016-06-13 |
| Date Mfgr Received | 2016-06-13 |
| Date Added to Maude | 2009-01-15 |
| 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 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Street | WERTSTRASSE 17 |
| Manufacturer City | EGGENDORF, DE 94469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 94469 |
| 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 | 2008-12-04 |
| 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 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Address | WERTSTRASSE 17 DEGGENDORF, DE 94469 GM 94469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-04 |