MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-12-06 for PROFILE ORIFICE OPENER FILE OS0219 manufactured by Dentsply Tulsa.
[552908]
Doctor reported a file separated in canal during procedure. Retrieval of the separated piece was attempted by the doctor, but was unsuccessful. The patient was referred to a specialist, though it is not known as of this report if the separated piece was successfully retrieved.
Patient Sequence No: 1, Text Type: D, B5
[7913150]
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. Device was not returned for evaluation and the lot number is not known for retained-product testing and/or dhr review. Further information regarding patient status will be submitted if it becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2004-00523 |
| MDR Report Key | 800684 |
| Report Source | 05 |
| Date Received | 2004-12-06 |
| Date of Report | 2004-11-08 |
| Date of Event | 2004-11-08 |
| Date Mfgr Received | 2004-11-08 |
| Date Added to Maude | 2007-01-08 |
| 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 | SUSQUEHANNA COMMERCE CENTER W. 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 FILE |
| Generic Name | DENTAL HAND INSTRUMENT |
| Product Code | EMR |
| Date Received | 2004-12-06 |
| Model Number | NA |
| Catalog Number | OS0219 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 788223 |
| 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 | 2004-12-06 |