inforMED
InjuryEMA

3M¿ KETAC¿ CEM PLUS AUTOMIX

Received May 28, 2026 · Event occurred Dec 15, 2025

Report 3005174370-2026-00001 · MDR key 25325250

Device

Generic name

Cement, Dental

Model number

3536TK

Catalog number

3536TK

Lot number

NI

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

74 YR · Unknown

  • Taste Disorder

Narrative

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL BRIDGE PLACEMENT PROCEDURE IN WHICH THE BRIDGE WAS CEMENTED USING 3M¿ KETAC¿ CEM PLUS AUTOMIX. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED A COMPLETE LOSS OF TASTE. THE LOSS OF TASTE REPORTEDLY BEGAN AFTER PLACEMENT OF THE BRIDGE AND HAS PERSISTED CONTINUOUSLY TO THE PRESENT DATE.