MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-04 for PROFILE GT ROTARY INSTRUMENT GTR0602025 manufactured by Dentsply Tulsa.
[18492686]
It was reported that a file separated in the canal during a procedure. The canal was filled with the separated piece in place. No further treatment is planned.
Patient Sequence No: 1, Text Type: D, B5
[18725172]
In this incident, there was no report of injury to the pt. 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. This event; therefore, is reportable per 21cfr part 803. Four unused files were returned and evaluated for land-width and diameter measurements and found to be in specification. Also, a dhr review was conducted; no abnormalities were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2005-00443 |
| MDR Report Key | 766864 |
| Report Source | 05 |
| Date Received | 2005-11-04 |
| Date of Report | 2005-10-05 |
| Date of Event | 2005-10-04 |
| Date Mfgr Received | 2005-10-05 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-10-06 |
| 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 GT ROTARY INSTRUMENT |
| Generic Name | DENTAL FILE |
| Product Code | EMR |
| Date Received | 2005-11-04 |
| Returned To Mfg | 2005-10-12 |
| Model Number | NA |
| Catalog Number | GTR0602025 |
| Lot Number | 061305018 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 754762 |
| 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 | GTR0602025 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-04 |