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 GTR1002025 manufactured by Dentsply Tulsa.
[696361]
Doctor reported that file separated in canal during procedure. The separated piece was visible in orifice, though it was not reported if removal occurred. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[7876819]
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. Product will not be returned and lot number is unknown for retained-product testing and/or dhr review. Therefore, no further testing is possible. Patient follow-up information will be provided if it becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2004-00457 |
| MDR Report Key | 910220 |
| Report Source | 05 |
| Date Received | 2004-10-29 |
| Date of Report | 2004-10-01 |
| Date of Event | 2004-09-30 |
| Date Mfgr Received | 2004-10-01 |
| 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 |
| Model Number | NA |
| Catalog Number | GTR1002025 |
| 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 | 884025 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | * JOHNSON CITY TN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-29 |