FDA Adverse Event
Injury
Summary report: N
KERRISON RONGEUR (40 DEG FWD), 2MM
MDR report key: 1045353
·
Received May 14, 2008
Report
- Report Number
- 1649384-2008-00263
- Event Type
- Injury
- Date Received
- May 14, 2008
- Date of Event
- April 11, 2008
- Report Date
- May 14, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HTX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.
Description of Event or Problem · 1
ON APR 15, 2008, THE DISTRIBUTOR REPORTED THAT DURING A MINIMAL INVASIVE SURGERY, THE TIP OF THE KERRISON RONGUER BROKE. THE SURGEON RETRIEVED THE BROKEN PIECES FROM THE WOUND. THE SURGEON FINISHED THE CASE BY USING THE OTHER KERRISON THAT WAS IN THE KIT. THERE WAS NO REPORTED SURGICAL DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KERRISON RONGEUR (40 DEG FWD), 2MM | HARMONY | HTX | ABBOTT SPINE | 18ZF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |