MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-08 for GATES GLIDDEN DRILL #4 * 100-2107 manufactured by Les Fils D'auguste Maillefer S.a..
[329579]
Pt visited dentist in emergency clinic on sunday for treatment of the upper left 2. Gates glidden drill #4 sheared off into the cavity. Dentist unable to remove. Pt went to their own dentist, who was unable to remove the drill from the pulp; filled around it. To co's knowledge, pt is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2004-12406 |
| MDR Report Key | 542786 |
| Date Received | 2004-09-08 |
| Date of Report | 2004-09-08 |
| Date of Event | 2004-09-05 |
| Date Facility Aware | 2004-09-08 |
| Report Date | 2004-09-08 |
| Date Reported to FDA | 2004-09-08 |
| Date Reported to Mfgr | 2004-09-08 |
| Date Added to Maude | 2004-09-13 |
| 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 | 3 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GATES GLIDDEN DRILL #4 |
| Generic Name | ENDODONTIC DEVICE |
| Product Code | EKP |
| Date Received | 2004-09-08 |
| Model Number | * |
| Catalog Number | 100-2107 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 532154 |
| Manufacturer | LES FILS D'AUGUSTE MAILLEFER S.A. |
| Manufacturer Address | * BALLAIQUES SZ CH-1338 |
| Baseline Brand Name | GATES GLIDDEN DRILL #4 |
| Baseline Generic Name | ENDODONTIC DEVICE |
| Baseline Model No | * |
| Baseline Catalog No | 100-2107 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-08 |