MAUDE Adverse Event Report: GC AMERICA INC. GC FUJICEM 2 RESIN MODIFIED GLASS IONMER CEMENT; CEMENT, DENTAL

Lot Number 1912182

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2021

Event Type  malfunction  

Event Description

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).

• Brand Name: GC FUJICEM 2 RESIN MODIFIED GLASS IONMER CEMENT
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): GC AMERICA INC.
• MDR Report Key: 11975828
• MDR Text Key: 255922257
• Report Number: MW5101808
• Device Sequence Number: 1
• Product Code: EMA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/17/2021
• Device Lot Number: 1912182
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 60