ULTRACAL XS
Received Jan 15, 2018 · Event occurred Oct 21, 2015
Report 1718912-2017-00041 · MDR key 7191190
Device
Generic name
Calcium Hydroxide Cavity Liner
Manufacturer
Ultradent Products IncCatalog number
1027
Lot number
BB5B2
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Numbness
- Numbness
Narrative
Additional Manufacturer Narrative
RETAINS OF LOT BB5B2 WERE TESTED AND FOUND THE PRODUCT TO MEET SPECIFICATIONS. EXPRESSING THROUGH THE APEX DURING ROOT CANAL THERAPY CAN HAPPEN. REPORTED DUE TO THE FACT THE PATIENT WAS GIVEN MEDISTEROL, (STEROID PACK) TO REDUCE INFLAMATION, THIS IS REPORTABLE PER 21 CFR 803. PATIENT STARTED THE STEROID AND WAS MONITORED. ULTRACAL WILL RESORB OVER TIME. IN HOUSE CLINICAN SUGGESTED TO BRING PATIENT BACK FOR AN XRAY IN 7-10 DAYS.
Description of Event or Problem
DR STATED HE EXPRESSED SOME ULTRACAL PASSED THE APEX OF THE TOOTH #29. HE PROCEEDED TO FINISH THE ROOT CANAL THERAPY. IT APPEARED THAT THE ULTRACAL MAY HAVE VIOLATED THE INFERIOR AVELAR NERVE SPACE. THE PATIENT IS REPORTED A BURNING SENSATION IN THE CORNER OF HIS MOUTH.