FDA Adverse Event
Malfunction
Summary report: N
CERAMO RONGEUR
MDR report key: 4973767
·
Received July 27, 2015
Report
- Report Number
- 9615005-2015-00001
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Date of Event
- January 11, 2013
- Report Date
- July 25, 2015
- Manufacturer
- FEHLING INSTRUMENTS, GMBH
- Product Code
- HTX
- PMA / PMN Number
- EXEMPT
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE 1MM CERAMO RONGEUR IS NOT MARKETED FOR USE IN THE LUMBAR REGION OF THE SPINE.
Description of Event or Problem · 1
SURGEON USING 1MM KERRISON DURING LUMBAR DISC PROCEDURE. TIP BROKE OFF AND WAS RECOVERED. [NOTE: 1MM KERRISON IS VERY DELICATE INSTRUMENT WHICH IS NOT RECOMMENDED FOR LUMBAR SPINE PROCEDURES].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487694 | CERAMO RONGEUR | KERRISON RONGEUR | HTX | FEHLING INSTRUMENTS, GMBH | NNS-1 | 22171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |