FDA Adverse Event
Injury
Summary report: N
BAK INSTRUMENT
MDR report key: 265644
·
Received February 24, 2000
Report
- Report Number
- 2184052-2000-00001
- Event Type
- Injury
- Date Received
- February 24, 2000
- Date of Event
- January 26, 2000
- Report Date
- February 24, 2000
- Manufacturer
- SULZER SPINE-TECH
- Product Code
- HTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT'S DURA WAS TORN BY THE FINAL REAMER DURING PREPARATION OF THE IMPLANT SITE FOR THE BAK DEVICE. THE DURAL TEAR WAS REPAIRED, AND PEDICLE SCREW WERE PLACED. THE BAK DEVICES WERE NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAK INSTRUMENT | REAMER | HTO | SULZER SPINE-TECH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |