MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-06-26 for PROFILE ORIFICE OPENER FILE OS0119 manufactured by Dentsply Tulsa.
[381012]
Reported separation a file in the pt's tooth during a dental procedure. The file was retrieved and there was no report of injury to the pt. The dentist started that the previous canal that he had shaped was very calcified. We explained that could have caused metal fatigue and contributed to the file malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2004-00329 |
| MDR Report Key | 600523 |
| Report Source | 05 |
| Date Received | 2004-06-26 |
| Date of Report | 2004-06-03 |
| Date of Event | 2004-06-02 |
| Date Mfgr Received | 2004-06-03 |
| Date Added to Maude | 2005-05-11 |
| 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., SUITE 60 SUSQUEHANNA COMMERCE CENTER W. |
| 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 | 2004-06-26 |
| Model Number | NA |
| Catalog Number | OS0119 |
| 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 | 590356 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | * JOHNSON CITY TN 37604 US |
| Baseline Brand Name | PROFILE ORIFICE OPENER FILES |
| Baseline Generic Name | DENTAL HAND INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | OS0119 |
| Baseline ID | NA |
| 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 | 1. Other | 2004-06-26 |