MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-05 for FLEX-R "S" #20 25MM 012-S4064 manufactured by Integra York, Pa Inc.
[2616511]
"files are breaking same spot regardless of lot, not flexible at all. " on (b)(4) 2012, add'l info was received: "the file broke inside the pt's tooth and was not able to be retrieved. No pt injury occurred. While performing root canal therapy the 25 mm size 20 flex-r files with stops separated in a canal. The file was new. The dr attempted to remove the broken segments and was unable to remove the broken piece. At this time the root canals have been completed and the pts will be monitored to see if any other treatment is needed. The endodontic therapy could eventually fail due to the files in the canals. The pts will be recalled for radiographs at 6 months, 12 months and 24 months post treatment. "
Patient Sequence No: 1, Text Type: D, B5
[9800608]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00039 |
| MDR Report Key | 2534692 |
| Report Source | 05,06 |
| Date Received | 2011-04-05 |
| Date of Report | 2012-04-05 |
| Date Mfgr Received | 2012-03-27 |
| Date Added to Maude | 2012-05-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX-R "S" #20 25MM |
| Generic Name | M50 - ENDODONTICS |
| Product Code | EKJ |
| Date Received | 2011-04-05 |
| Catalog Number | 012-S4064 |
| Lot Number | 330P1112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-05 |