inforMED
OtherEBC

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 Products

Model number

5900

Catalog 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