MalfunctionEKG
PROTAPER NT ROTARY FILE
Received Apr 20, 2006
Report 8031010-2006-00146 · MDR key 703740
Device
Product problems
- Device, or device fragments remain in patient
- Material Separation
Patient
UNKNOWN
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
EIGHT TO TEN FILES SEPARATED DURING A TWO MONTH PERIOD. FURTHER INFORMATION WAS REQUESTED THOUGH NONE IS AVAILABLE AS OF THIS REPORT.