FDA Adverse Event
Other
Summary report: N
BAXANO IO-FLEX MICROBLADE SHAVER
MDR report key: 2915195
·
Received January 10, 2013
Report
- Report Number
- 3006324586-2013-00001
- Event Type
- Other
- Date Received
- January 10, 2013
- Date of Event
- December 14, 2012
- Report Date
- January 10, 2013
- Manufacturer
- BAXANO, INC.
- Product Code
- HAE
- PMA / PMN Number
- K100958
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT UNDERWENT A LEFT L3/4 DISCECTOMY AND DECOMPRESSION USING THE BAXANO IO-FLEX SYS. DURING DECOMPRESSION WITH THE 10 MM BAXANO IO-FLEX MICROBLADE SHAVER DEVICE AT THE LEFT L3/4 FORAMEN, THE SUPERIOR ARTICULATING PROCESS (SAP) FRACTURED. THE SURGEON STATED THAT USE OF A TAYLOR RETRACTOR WHICH HAD BEEN HAMMERED INTO THE LATERAL ASPECT OF THE SAP WHERE IT MEETS THE BASE OF THE TRANSVERSE PROCESS CONTRIBUTED TO THE BONE FRACTURE. THE PT WAS REPORTEDLY DOING FINE POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15780 | BAXANO IO-FLEX MICROBLADE SHAVER | RONGEUR, MANUAL | HAE | BAXANO, INC. | IO-MBS10SC | 101030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |