ENDOREZ CANAL SEALER
Received Oct 18, 2011 · Event occurred Sep 22, 2011
Report 1718912-2011-00007 · MDR key 2305999
Device
Generic name
Endodontic Filler & Sealer
Manufacturer
Ultradent ProductsModel number
5900Catalog number
5900
Lot number
B76WX
Product problems
- Patient-Device Incompatibility
Patient
35 YR
- Inflammation
- Pain
- Numbness
Narrative
Description of Event or Problem
DR (B)(6) IS A ORAL MAXILLOFACIAL SURGEON. HE REPORTED THE PT ALSO REPORTED PAIN. HE TOLD DR (B)(6), ULTRADENT'S IN-HOUSE DENTIST, HE HAD NOT DONE ANYTHING TO THE PT. HE WANTED INFO ON ENDOREZ. DR (B)(6) EXPLAINED THAT IT WAS A UDMA RESIN AND GAVE A LITTLE HISTORY ON THEM AS BONE CEMENTS. DR (B)(6) TOLD HIM NOT TO INVASIVELY TRY TO REMOVE THE CHEMICAL AS THIS WOULD QUITE POSSIBLY CAUSE MORE NERVE DAMAGE, HE AGREED. DR (B)(6) EXPLAINED THE IMMUNE MECHANISM OF FOREIGN BODY PHAGOCYTOSIS THAT WOULD BIO-ABSORB THIS MATERIAL OVER MONTHS TO A FEW YEARS AND THAT THE SYMPTOMS SHOULD SLOWLY RESOLVE WITH TIME. DR (B)(6) ADVISED THAT HE SHOULD F/U AT 6 MONTH INTERVALS AT FIRST AND GO FROM THERE. THE PT WAS REFERRED TO DR (B)(6) BY DR (B)(6), WHO CALLED AND EXPLAINED WHAT HAPPENED AT THE TIME OF INJURY. HE WAS BACK FILLING THE CANAL AND SOME OF THE ENDOREZ WENT INSIDE THE CANAL SPACE. THEY CAUGHT IT IMMEDIATELY AFTER ON THE PA. RIGHT AFTER THE PT WAS ASYMPTOMATIC AND AFTER 2 DAYS STARTED HAVING SOME INFLAMMATION AND THE NUMBNESS HAD NOT GONE AWAY. THAT IS WHEN HE REFERRED THE PT TO DR (B)(6). NO OTHER ADVERSE EFFECTS OTHER THAN THE NUMBNESS.
Remedial action
- Patient Monitoring