FDA Adverse Event
Injury
Summary report: N
SATELLITE SPINAL SYSTEM
MDR report key: 1327953
·
Received February 27, 2009
Report
- Report Number
- 1030489-2009-00216
- Event Type
- Injury
- Date Received
- February 27, 2009
- Report Date
- February 5, 2009
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- NVR
- PMA / PMN Number
- K051320
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN IMPLANTED SPHERE DEVICES WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SATELLITE SPINAL SYSTEM | SPHERE | NVR | WARSAW ORTHOPEDIC INC. | NA | W05K0557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |