MalfunctionEMA
GC FUJICEM 2 RESIN MODIFIED GLASS IONMER CEMENT
Received Jun 9, 2021 · Event occurred May 14, 2021
Report MW5101808 · MDR key 11975828
Device
Generic name
Cement, Dental
Lot number
1912182
Product problems
- Loss of or Failure to Bond
Patient
64 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
GC FUJICEM 2 WHICH IS A LUTING CEMENT FOR DENTAL CROWNS, DOES NOT POLYMERIZE. THEREFORE THE DENTAL CROWN FAILED TO BOND TO THE TOOTH STRUCTURE. FDA SAFETY REPORT ID # (B)(4).