inforMED
InjuryEMA

G-CEM LINKACE

Received Aug 19, 2015 · Event occurred Jul 21, 2015

Report 1410097-2015-00003 · MDR key 5032730

Device

Generic name

Self Adhesive Resin Cement

Manufacturer

Gc Corp.

Catalog number

004857

Lot number

1409031

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Sensitivity of Teeth

Narrative

Description of Event or Problem

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.