MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-11-05 for PROFILE GT ROTARY INSTRUMENT GTR0603025 manufactured by Dentsply Tulsa.
[585499]
Doctor reported a file separated in canal during initial use. The patient is scheduled for a follow-up visit to attempt retrieval of the separated piece. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[7920549]
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 illnesss that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function as evidence by previous reported events. This event, therefore, is reportable per 21cfr part 803. Device was not returned for evaluation and the lot number is not known for retained-product testing and/or dhr review. Information pertaining to patient outcome will be submitted in a follow-up report if it becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2004-00489 |
| MDR Report Key | 826574 |
| Report Source | 05 |
| Date Received | 2004-11-05 |
| Date of Report | 2004-10-14 |
| Date of Event | 2004-10-14 |
| Date Mfgr Received | 2004-10-14 |
| Date Added to Maude | 2007-03-13 |
| 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 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 GT ROTARY INSTRUMENT |
| Generic Name | DENTAL FILE |
| Product Code | EKA |
| Date Received | 2004-11-05 |
| Model Number | NA |
| Catalog Number | GTR0603025 |
| 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 | 813962 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | * JOHNSON CITY TN * US |
| Baseline Brand Name | PROFILE GT ROTARY INSTRUMENT |
| Baseline Generic Name | DENTAL FILE |
| Baseline Model No | NA |
| Baseline Catalog No | GTR0603025 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-05 |