MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-11-19 for SATELLITE SPINAL SYSTEM 9000213 manufactured by Sofamor Danek Deggendorf Gmbh.
[15159324]
Date of implant: 2007. It was reported that a patient underwent a surgical procedure with implantation of a sphere device at l5-s1. Patient complains of chronic pain unrelieved after surgery. Positive discogram indicates that patient is symptomatic at an adjacent level. Approximately 6 months post-op, patient underwent revision surgery to remove the sphere device l5-s1 and an alif at l4-s1 was performed. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[15392109]
Device has not been explanted; therefore, product evaluation is not possible. Unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2007-00354 |
| MDR Report Key | 952526 |
| Report Source | 07 |
| Date Received | 2007-11-19 |
| Date of Report | 2007-10-31 |
| Date Mfgr Received | 2007-10-31 |
| Date Added to Maude | 2008-01-31 |
| 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 | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Street | WERTSTRASSE 17 |
| Manufacturer City | DEGGENDORF 94469 |
| Manufacturer Postal Code | 94469 |
| 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 | 2007-11-19 |
| Model Number | NA |
| Catalog Number | 9000213 |
| Lot Number | LX55 |
| 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 | 950069 |
| Manufacturer | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Address | WERTSTRASSE 17 DEGGENDORF 94469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-19 |