MalfunctionEMG
VANTAGE 151 EXTR FCPS SER
Received May 21, 2014 · Event occurred Apr 21, 2014
Report 2523190-2014-00028 · MDR key 3897123
Device
Generic name
M51 - General Dentistry
Manufacturer
Integra York, Pa Inc.Catalog number
V90-151-SG
Lot number
UNK
Product problems
- Break
- Detachment Of Device Component
Patient
46 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
CUSTOMER INITIALLY REPORTED BROKEN TIP. ON (B)(6) 2014 DENTAL ASSISTANT REPORTS NO HARM DONE, NO RISK FOR HARM UNDER THE CIRCUMSTANCES, MEASURES TO PREVENT SWALLOWING PIECES ARE USED. DOCTOR WAS DOING AN EXTRACTION AND ONE OF THE JAWS BROKE OFF AND WAS IMMEDIATELY RETRIEVED.