MAUDE Adverse Event Report: GC CORP. G-CEM LINKACE; SELF ADHESIVE RESIN CEMENT

Catalog Number 004857

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sensitivity of Teeth (2427)

Event Date 07/21/2015

Event Type  Injury  

Event Description

Dentist's office reported two cases of post op sensitivity after the dentist had used g-cem linkace on the patients.Both patients complained of sensitivity to hot and cold.Doctor had both patients go through root canal therapy.Doctor is not sure if the cement contributed to the sensitivity problem.Patients are now fine.

• Brand Name: G-CEM LINKACE
• Type of Device: SELF ADHESIVE RESIN CEMENT
• Manufacturer (Section D): GC CORP.; 76-1 hasunuma-cho; itabashi-ku; tokyo ; JA
• Manufacturer (Section G): GC AMERICA, INC.; 3737 west 127th st.; alsip IL 60803
• Manufacturer Contact: 3737 west 127th st.; alsip, IL 60803
• MDR Report Key: 5032730
• MDR Text Key: 24230946
• Report Number: 1410097-2015-00003
• Device Sequence Number: 1
• Product Code: EMA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2016
• Device Catalogue Number: 004857
• Device Lot Number: 1409031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/22/2015
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• 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 Outcome(s): Other