ORTHO SOLO
Received Jun 19, 2017 · Event occurred May 4, 2017
Report 2016150-2017-00001 · MDR key 6649985
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Sensitivity of Teeth
- Sensitivity of Teeth
Narrative
Additional Manufacturer Narrative
IT WAS ALLEGED THAT A PATIENT LOST ENAMEL TO TEETH. IT WAS CONFIRMED THAT NO SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THE DOCTOR FIXED THE PATIENTS TEETH THAT LOST THE ENAMEL AND A NEW DEVICE WAS REPLACED. TO DATE THE PATIENT IS DOING FINE.
Description of Event or Problem
IT WAS ALLEGED THAT A PATIENT LOST ENAMEL TO TEETH WHILE USING ORTHO SOLO.
Additional Manufacturer Narrative
THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS.
Description of Event or Problem
IT WAS ALLEGED THAT A PATIENT LOST ENAMEL TO TEETH WHILE USING ORTHO SOLO.