FDA Adverse Event
Malfunction
Summary report: N
KMEDIC PIN CUTTER SIDE CUTT. 15" MAX. 4.0MM
MDR report key: 2497930
·
Received March 15, 2012
Report
- Report Number
- 3005236665-2012-00003
- Event Type
- Malfunction
- Date Received
- March 15, 2012
- Date of Event
- February 9, 2012
- Report Date
- February 23, 2012
- Manufacturer
- KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL
- Product Code
- FZT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: "CUSTOMER ALLEGES THE TIP BROKE OFF OF THE ROD DURING A CERVICAL 360 PROCEDURE. NO PIECE WAS LEFT IN THE PATIENT AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION." PATIENT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KMEDIC PIN CUTTER SIDE CUTT. 15" MAX. 4.0MM | PIN CUTTER | FZT | KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL | E11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |