FDA Adverse Event
Summary report: N
SPINEOLOGY E SHAPER BLADE
MDR report key: 1962688
·
Received December 30, 2010
Report
- Report Number
- 1962688
- Date Received
- December 30, 2010
- Date of Event
- October 15, 2010
- Report Date
- December 30, 2010
- Manufacturer
- SPINEOLOGY, INC.
- Product Code
- MDM
- Report Source
- User Facility report
- Reporter Location
- KY, US
Narratives
Description of Event or Problem · 1
DURING A LUMBAR LAMINECTOMY AND FUSION L4-5, L5-S1 THE TIP OF THE SPINEOLOGY SHAVER BLADE BROKE OFF IN THE L5 DISC SPACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINEOLOGY E SHAPER BLADE | INSTRUMENT, SURGICAL | MDM | SPINEOLOGY, INC. | 315-0014 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |