MalfunctionEGS
CONTRA ANGLE 20:1, IMPLANT HANDPIECE
Received Jul 12, 2018 · Event occurred Oct 25, 2017
Report 9680741-2018-00004 · MDR key 7681218
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PER COMPLAINT#: (B)(4), COMPLAINANT (DENTIST) REPORTS A DEVICE MALFUNCTION FOR VENDOR PART, NOUVAG IMPLANT MACHINE MD11, IN WHICH THE LATCH SYSTEM ON HANDPIECE FAILED AND BURR FELL OUT OF HANDPIECE INTO PT'S MOUTH DURING A CLINICAL DENTAL IMPLANT PROCEDURE. THE PROCEDURE WAS COMPLETED IN THE SAME VISIT AND NO PATIENT IMPACT WAS REPORTED.
Remedial action
- Repair