NEXUS RMGI
Received Aug 1, 2014
Report 2024312-2014-00500 · MDR key 3973872
Device
Product problems
- Failure To Adhere Or Bond
Patient
Not reported
- Failure of Implant
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED THE LOSS OF A CROWN AFTER PLACEMENT WITH THE NEXUS RMGI PRODUCT. THIS IS THE FIRST OF TWO (2) REPORTS.
Additional Manufacturer Narrative
PATIENT SPECIFIC WITH REGARD TO AGE AND WEIGHTS WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR CLEANED THE CROWN FOR TOOTH #18 AND RE-CEMENTED THE CROWN FOR THE PATIENT DURING THE SAME VISIT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE RETURNED PRODUCT WAS RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE; THEREFORE, A 'GEL TIME' AND 'SET TIME' TESTS OF THE RETAIN SAMPLE WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARDS TO THIS LOT.