MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-29 for PROFILE GT ROTARY INSTRUMENT GTR0606025 manufactured by Dentsply Tulsa.
[17865811]
Doctor reported that file separated in canal during procedure. Doctor elected to fill to the separated piece and monitor patient. There is no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[17912995]
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 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. Testing results (attached) indicate that other than the breakage, the file showed no defects.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2004-00458 |
| MDR Report Key | 910151 |
| Report Source | 05 |
| Date Received | 2004-10-29 |
| Date of Report | 2004-09-30 |
| Date of Event | 2004-09-30 |
| Date Mfgr Received | 2004-09-30 |
| Date Added to Maude | 2007-09-12 |
| 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 | SUSEQUEHANNA 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 DR |
| 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 | 2004-10-29 |
| Returned To Mfg | 2004-10-22 |
| Model Number | NA |
| Catalog Number | GTR0606025 |
| Lot Number | UNK |
| 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 | 884005 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | * JOHNSON CITY TN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-29 |