MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-21 for EPIPHANY manufactured by Sybronendo.
[5387394]
A doctor alleged that two (2) patients had required endodontic re-treatment for root canals that had previously been filled with epiphany. This is the first of two (2) reports.
Patient Sequence No: 1, Text Type: D, B5
[12972411]
Specific patient information such as age and weight was not provided. The doctor reported that the initial root canal treatment was performed approximately five (5) years ago by a different endodontist and that epiphany root canal sealant material had been used for the initial procedure. The doctor diagnosed the tooth with a par lesion associated with the palatal root. The doctor cleaned the affected root canals in the patient's tooth, packed it with calcium hydroxide, and prescribed antibiotics for treatment. The doctor reported that black material was found within the root canal during re-treatment and removal of the epiphany material. The patient will return to the office at a later date for completion of the root canal procedure. At this time, the patient is doing fine. Sybronendo has requested that the customer report any new information with regard to this patient. An update will be provided if any new information becomes available. The product involved in the alleged incident was not returned and no lot number was provided; therefore, no further evaluation can be conducted. Upon the investigations of previous comparable incidents, it was found that the black material seen within the product was bismuth sulfide. It is produced by the reaction between bismuth oxychloride in the realseal root canal filler and a protein (most likely from a bodily fluid). The possible causes for the formation of bismuth sulfide are primarily due to technique variations and deviations from the instructions for use of the realseal system, and include overheating and incomplete flushing of naocl from the root canal. Overheating can degrade the realseal 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 bismuth sulfide. This mdr is being submitted because of the medical intervention for retreatment. The previous investigations 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 | 2016150-2015-00001 |
| MDR Report Key | 4438981 |
| Report Source | 05 |
| Date Received | 2015-01-21 |
| Date of Report | 2014-12-31 |
| Date Mfgr Received | 2014-12-31 |
| Date Added to Maude | 2015-01-21 |
| 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 |
| 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 | EPIPHANY |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2015-01-21 |
| Operator | OTHER |
| 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 | 2015-01-21 |