MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-05-20 for FLEX-R 'S' #20 25MM 012-S4064 manufactured by Itegra York, Pa Inc..
[5804874]
Customer initially reports that 2 files broke off in patients mouths. Piece could not be removed from root canal, no ill effects seen. Number 2 of 2 related complaints.
Patient Sequence No: 1, Text Type: D, B5
[13403850]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[63943110]
On 06/15/2015 integra completed investigation. Results- failure analysis: dental files returned in used condition, not showing any unusual markings. The files were showing wear upon visually inspecting the files, it is noticed that some of the files are bent and one with a broken tip. Quality inspector tested the blades for bend and torque, and the files tested within defined specifications. Without knowing how much pressure was used during the procedure, the cause of the complaint is undetermined. Device history evaluation- nonconforming product report/nonconforming material report history: none, variance authorization/deviation history none, engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history, corrective action preventive action history: none, health hazard evaluation history: none. Conclusion: the complaint report cannot be confirmed, due to the instrument testing within defined specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00025 |
| MDR Report Key | 4790480 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-05-20 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-04-28 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-05-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| 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 | 2015-05-20 |
| Returned To Mfg | 2015-05-14 |
| Catalog Number | 012-S4064 |
| Lot Number | 19052 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-20 |