MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-19 for ATR TECNIKA A0410 SX UNK manufactured by Atr.
[306674]
Dentist reported having an instrument breakage ("blocked") during a root canal. Dentist sent back broken instruments with atr tecnika and requested the motor be checked and repaired if necessary as "files are breaking. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643003-2002-00059 |
| MDR Report Key | 434049 |
| Date Received | 2002-12-19 |
| Date of Report | 2002-11-15 |
| Date Facility Aware | 2002-11-15 |
| Report Date | 2002-12-19 |
| Date Reported to FDA | 2002-12-19 |
| Date Reported to Mfgr | 2002-12-19 |
| Date Added to Maude | 2002-12-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATR TECNIKA |
| Generic Name | ENDODONTIC MOTOR |
| Product Code | ELB |
| Date Received | 2002-12-19 |
| Model Number | A0410 SX |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 423002 |
| Manufacturer | ATR |
| Manufacturer Address | VIA DEL PESCINO 6 PISTOIA IT 51100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-19 |