NEXUS RMGI
Received Aug 27, 2014
Report 2024312-2014-00572 · MDR key 4041630
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Complaint, Ill-Defined
Narrative
Additional Manufacturer Narrative
SPECIFIC INFORMATION WITH REGARD TO THE PATIENT AGE AND WEIGHT WAS NOT PROVIDED BY THE DOCTOR. THE DOCTOR RE-CEMENTED THE CROWN FOR THE PATIENT USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT ALLEGED IN THIS INCIDENT WAS NOT RETURNED; THEREFORE, AN ADHESIVE STRENGTH TEST OF A RETAIN SAMPLE WAS PERFORMED, 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 REGARD TO THIS LOT.
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED THE LOSS OF A CROWN AFTER PLACEMENT WITH THE NEXUS RMGI PRODUCT.