REALSEAL POINTS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-09 for REALSEAL POINTS manufactured by Sybronendo.

Event Text Entries

[4856625] A doctor's office alleged that for the realseal points, twenty-seven (27) patients had required the re-treatment of a root canal due to the presence of black material within the canal. This is the fourteenth of twenty-seven (27) reports.
Patient Sequence No: 1, Text Type: D, B5


[12227474] Although the doctor identified three (3) different lots associated with the presence of black material within the canal, the doctor could not verify which lot had been used on any of the patients; therefore, no lot numbers were identified in section d-4 of this report. The lots involved in the alleged incident include lot numbers ge12110988, ge12101160, and ge1111854. The initial root canal procedure had taken place on (b)(6) 2009. The doctor repeated the root canal procedure on the patient's tooth on (b)(6) 2012. To date, the patient is doing fine. A visual evaluation was performed on the returned product, yielding results within specifications. Prior investigations have concluded that the black material causing the darkening of the root canal was bismuth sulfide, which is the result of a reaction between the bismuth oxychloride in the real seal root canal filler and a protein (most likely from a bodily fluid). The possible causes for the formation of the bismuth sulfide are primarily due to technique variations and deviations from the instructions for use of the real seal system, and include overheating and incomplete flushing of naocl from the root canal. Overheating can degrade the real seal root canal filler and possibly lead to improper sealing and leaking, which can result in the leeching of proteins into the root canal and subsequent bismuth sulfide formation. Failure to completely flush all naocl from the root canal can also result in the formation of bismuth sulfide. Retreatment of patients' root canals is required to remove the bismuth sulfide. This mdr is being submitted because of this medical intervention. These investigations have led to the conclusion that the product itself, when used according to the instructions for use, performs as intended and yields acceptable results.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2016150-2014-00452
MDR Report Key4071359
Report Source05
Date Received2014-09-09
Date of Report2014-08-12
Date Mfgr Received2014-08-12
Date Added to Maude2014-09-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 W. COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
Manufacturer G1SYBRONENDO
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREALSEAL POINTS
Generic NameGUTTA-PERCHA
Product CodeEKM
Date Received2014-09-09
OperatorDENTIST
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYBRONENDO
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-09-09

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