MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-04-21 for PROFILE GT ROTARY INSTRUMENT GTR0804025 manufactured by Dentsply Tulsa.
[15005693]
The dr reported separating a file in the pt's tooth during a dental procedure. It was also reported that the dr was not changing the settings on the dtc console to reflect the file being used. The pt was referred to an endodontist for further treatment. The file was retrieved and there was no report of injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2004-00204 |
| MDR Report Key | 552103 |
| Report Source | 05 |
| Date Received | 2004-04-21 |
| Date of Report | 2004-03-22 |
| Date of Event | 2004-03-22 |
| Date Mfgr Received | 2004-03-22 |
| Date Added to Maude | 2004-10-29 |
| 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 SUSQUEHANNA COMMERCE CTR 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 GT ROTARY INSTRUMENT |
| Generic Name | DENTAL FILE |
| Product Code | EMR |
| Date Received | 2004-04-21 |
| Model Number | NA |
| Catalog Number | GTR0804025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 541637 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | 608 ROLLING HILLS DR. JOHNSON CITY TN 37604 US |
| Baseline Brand Name | PROFILE GT ROTARY INSTRUMENT |
| Baseline Generic Name | DENTAL FILE |
| Baseline Model No | NA |
| Baseline Catalog No | GTR0804025 |
| Baseline ID | 061902-761 (LOT |
| Baseline Device Family | PROFILE GT |
| Baseline Shelf Life [Months] | NA |
| 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 | 2004-04-21 |