MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-29 for PROFILE ORIFICE OPENER FILES OS0219 manufactured by Dentsply Tulsa.
[490528]
It was reported that two files from the same lot separated on the same patient. The root canal therapy was completed by incorporating the separated pieces into the fill.
Patient Sequence No: 1, Text Type: D, B5
[7787782]
In this incident there was no report of injury to the patient. However, as a result of this malfunction, the potential for surgical intervention exists (though inadvisable per expert opinion provided by dr. ) to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files. This event, therefore, is reportable per 21cfr part 803. The device was returned for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available. Two lot numbers were provided by the initial reporter: 033006251 (manufactuer 03/30/2006) and 010406215 (manufactured 01/04/2006). It is unk which, if either, was involved in the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2006-00276 |
| MDR Report Key | 734333 |
| Report Source | 05 |
| Date Received | 2006-06-29 |
| Date of Report | 2006-05-31 |
| Date Mfgr Received | 2006-05-31 |
| Date Added to Maude | 2006-07-17 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST., STE. 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY TULSA |
| Manufacturer Street | 608 ROLLING HILLS DRIVE |
| Manufacturer City | JOHNSON CITY TN 37604 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROFILE ORIFICE OPENER FILES |
| Generic Name | EMR |
| Product Code | EMR |
| Date Received | 2006-06-29 |
| Returned To Mfg | 2006-06-15 |
| Model Number | NA |
| Catalog Number | OS0219 |
| Lot Number | SEE H.10 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 722204 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | * JOHNSON CITY TN * US |
| Baseline Brand Name | PROFILE ORIFICE OPENER FILES |
| Baseline Generic Name | DENTAL HAND INSTRUMENT |
| Baseline Catalog No | OS0219 |
| Baseline Device Family | PROFILE ORIFICE OPENER FILES |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-29 |