FDA Adverse Event
Injury
Summary report: N
PITUITARY RONGEUR (UP), 2MM
MDR report key: 1080967
·
Received July 23, 2008
Report
- Report Number
- 1649384-2008-00383
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- June 30, 2008
- Report Date
- July 23, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HTX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. EVAL PENDING.
Description of Event or Problem · 1
IN 2008, THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON WAS USING THE INSTRUMENT WHEN THE UPPER JAW BROKE WHILE USING IT IN THE DISC SPACE. THE BROKEN PIECE WAS RETRIEVED FROM THE WOUND WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PITUITARY RONGEUR (UP), 2MM | HARMONY | HTX | ABBOTT SPINE | 38CE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |