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.
[4739344]
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 fifth of twenty-seven (27) reports.
Patient Sequence No: 1, Text Type: D, B5
[12332877]
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 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) 2008. The doctor repeated the root canal procedure on the patient's tooth on (b)(6) 2009. The patient was still experiencing issues; therefore, the patient was referred to an endodontist in (b)(6) 2011. The doctor's office was not definitive as to what treatment the patient received from the endodontist; however, they stated that 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
| Report Number | 2016150-2014-00443 |
| MDR Report Key | 4071305 |
| Report Source | 05 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-08-12 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W. COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | SYBRONENDO |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REALSEAL POINTS |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2014-09-09 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYBRONENDO |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-09-09 |