FDA Adverse Event Injury Summary report: N

RESILON

MDR report key: 3065998 · Received April 12, 2013

Report

Report Number
MW5029782
Event Type
Injury
Date Received
April 12, 2013
Date of Event
April 8, 2003
Report Date
April 12, 2013
Manufacturer
SYBRON ENDO
Product Code
EKR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

ENDODONTICS IS A PROCEDURE PERFORMED IN DENTISTRY TO REMOVE DISEASED PULP TISSUE WITHIN THE ROOTS OF TEETH THE ROOT CANAL SPACE IF FILLED WITH A ROOT FILLING. MOST COMMONLY THAT ROOT CANAL FILLING HAS BEEN COMPRISED OF A BIOCOMPATIBLE, INERT, AND STABLE MATERIAL CALLED GUTTA PERCHA. ABOUT 6 YEARS AGO, A NEW ROOT FILLING CAME ON THE MARKET CALLED RESILON WHICH IS EMPLOYED WITH A SEALER CALLED REALSEAL. THERE WERE ARTICLES SUGGESTING THAT IT MAY BE METABOLIZED BY BACTERIA THAT WERE PUBLISHED IN PEER REVIEW ARTICLES. HOWEVER, THE CAUTION OF THE MATERIAL WAS NOT HEEDED. BASED ON OTHER ARTICLES I EMPLOYED THE MATERIAL BECAUSE IT HAD ATTRIBUTES THAT I THOUGHT WERE MORE BENEFICIAL THAN GUTTA PERCHA. IN SOME INSTANCES, WHERE A ROOT CANAL WAS FAILING, I NOTICED THAT THE MATERIAL HAD DEGRADED SIGNIFICANTLY AND TURNED FROM A PINK SOLID TO A BLACK OR GREY MUSH. UNFORTUNATELY, THE DEGRADATION CANNOT BE DISCERNED ON A RADIOGRAPH. IN THIS PARTICULAR CASE, I DID NOT PERFORM THE ORIGINAL ROOT CANAL. HOWEVER, I DID PERFORM THE RETREATMENT OF THE ROOT CANAL AND FOUND THE ROOT FILLING TO BE DEGRADED. I DOCUMENTED THE CASE PHOTOGRAPHY THROUGH A MICROSCOPE, WHICH CAN BE FORWARDED ON IF DESIRED. I FEEL THAT I HAVE HAD ENOUGH CASES; MAYBE 5 OR 6 WHERE I MADE SIMILAR OBSERVATIONS SUCH THAT A SIGNIFICANT INQUIRY IS NECESSARY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
157505 RESILON RESILON EKR SYBRON ENDO

Patients

Seq Age Sex Outcome Treatment
1 37 YR Other