MAXCEM ELITE
Received Aug 22, 2018
Report 2024312-2018-00001 · MDR key 7805122
Device
Generic name
Cement
Manufacturer
Kerr CorporationProduct problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Sensitivity of Teeth
- Sensitivity of Teeth
Narrative
Additional Manufacturer Narrative
NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO AGE, WEIGHT, ETHNICITY, AND RACE. THE DATE OF EVENT WAS REPORTED AS BEING IN THE LAST TEN MONTHS, SPECIFIC DATE NOT PROVIDED. DEVICE MANUFACTURE DATE CANNOT BE DETERMINED BECAUSE THERE WAS NOT LOT NUMBER PROVIDED. THE PRODUCT WAS NOT RETURNED AND THERE WAS NO LOT NUMBER OR PART NUMBER PROVIDED, THEREFORE NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem
A COMPLAINANT ALLEGED THAT ONE (1) PATIENT HAD TO GET A ROOT CANAL DONE AFTER MULTIPLE DEBONDINGS AND CEMENTATIONS CAUSED SENSITIVITY.
Additional Manufacturer Narrative
AWARENESS DATE WAS CORRECTED.