CONTRA ANGLE 20:1, IMPLANT HANDPIECE
Received Jul 12, 2018 · Event occurred Nov 14, 2017
Report 9680741-2018-00006 · MDR key 7681189
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 REPORTS A DEVICE MALFUNCTION FOR VENDOR PART, NOUVAG IMPLANT MACHINE MD11. DOCTOR WAS PLACING A DENTAL IMPLANT USING KIT AND MD11 FOR 1ST TIME. THE BURS THEY USED FOR PLACEMENT OF 5.2 X 11 WOULDN'T LATCH INTO HANDPIECE. HE COULDNT DRILL TO DEPTH BECAUSE BUR KEPT COMING OUT OF HANDPIECE. DOCTOR WAS ABLE TO COMPLETE PROCEDURE IN SAME VISIT WITH A NEW HANDPIECE. NO PATIENT IMPACT WAS REPORTED, HOWEVER, IF THE REPORTED MALFUNCTION WERE TO RECUR, IN WORST CASE SCENARIO, THERE MIGHT BE A DELAY IN PROCEDURE IF THE DOCTOR DID NOT HAVE ANOTHER HANDPIECE AVAILABLE. NOUVAG HAS BEEN NOTIFIED OF THE ISSUE.
Remedial action
- Repair