InjuryEMA
SPEEDCEM PLUS
Received Apr 13, 2018 · Event occurred Feb 9, 2018
Report 9612352-2018-00001 · MDR key 7429052
Device
Product problems
- Use of Device Problem
Patient
Not reported
- Inflammation
- Pain
- Inflammation
- Pain
Narrative
Description of Event or Problem
A DENTIST REPORTED THAT AFTER USING SPEEDCEM PLUS TO CEMENT CROWNS, 5 PATIENTS EXPERIENCED BITE DISCOMFORT AND PULPITIS WITH PAIN. OF THOSE 5 PATIENTS 2 HAD TO UNDERGO ENDODONTIC TREATMENT. THE RELEVANT BATCH (681712WW) MET ALL THE SPECIFICATIONS AND QUALITY CRITERIA FOR RELEASE. THE INFORMATION PROVIDED SHOWED TWO POTENTIAL APPLICATION ERRORS BY THE DENTIST, WHICH MIGHT HAVE CONTRIBUTED TO THE POSTOPERATIVE SENSITIVITIES: THE ZIRCONIUM OXIDE CROWNS WERE ETCHED BEFORE INSERTION, WHICH IS NOT INDICATED. THE PREPARATION OF THE ABUTMENT TEETH WAS NOT RETENTIVE. DOCTOR DID NOT RETURN SPEEDCEM PLUS MATERIAL.