MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-17 for REALSEAL 972-2001 manufactured by Sybronendo.
[5714926]
A doctor's office alleged that multiple patients had experienced the retreatment of a root canal due to abscess after placement with realseal.
Patient Sequence No: 1, Text Type: D, B5
[13158305]
Specific number of patients and pateints' gender, age, and weight were not provided. The doctor re-treated the root canal for each of the patients, without further incident. To date, all the patients are doing fine. 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 | 2016150-2015-00015 |
| MDR Report Key | 4704384 |
| Report Source | 05 |
| Date Received | 2015-04-17 |
| Date of Report | 2015-03-20 |
| Date Mfgr Received | 2015-03-20 |
| Date Added to Maude | 2015-04-17 |
| 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 |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2015-04-17 |
| Catalog Number | 972-2001 |
| Lot Number | 091266978 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-04-17 |