D
Patient 1
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.
MAUDE MDR 1209055
- MDR report key
- 1209055
- Report number
- 1030489-2008-00579
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-08-28
- Date received
- 2008-10-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CHAD ASHTON
- Address
- 1800 PYRAMID PLACE MEMPHIS TN 38132 US
- Phone
- 901-901-9013
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SATELLITE SPINAL SYSTEM | SPHERE | MEDTRONIC SOFAMOR DANEK MANUFACTURING | NVR | NA | 8000211 | W05K0567 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-10-16 | 0 | 1. R |
Event Narratives#
N
Patient 1
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.