MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-12 for ELECTROTORQUE TLC WITH TORQUE LIMIT CONTROL 1003.5840 manufactured by Kaltenbach & Voigt Gmbh.
[18208275]
The file used was a tulsa dental profile gt #2, nickel titanium file. The patient was sent to a specialist for removal of the file. The specialist was unable to completely remove the file from the tooth canal. Canal was filled but short by about 5mm. The equipment was inspected and found at a different setting (1 to 1 ratio) than was originally set (3 to 1 ratio) at installation. The equipment functioned properly at the original setting.
Patient Sequence No: 1, Text Type: N, H10
[18239072]
While using the tlc endo setup during a root canal, the file broke in the patient's tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010493-2008-00015 |
| MDR Report Key | 1159183 |
| Report Source | 05 |
| Date Received | 2008-09-12 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-06-10 |
| Date Mfgr Received | 2008-08-14 |
| Date Added to Maude | 2008-09-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT, MANAGER |
| Manufacturer Street | 340 E MAIN ST |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8473643958 |
| Manufacturer G1 | KALTENBACH & VOIGT GMBH & CO. KG |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH D-88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROTORQUE TLC WITH TORQUE LIMIT CONTROL |
| Generic Name | DENTAL OPERATIVE UNIT AND ACCESSORIES |
| Product Code | EKK |
| Date Received | 2008-09-12 |
| Model Number | ELECTROTORQUE TLC |
| Catalog Number | 1003.5840 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1182379 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH GM D-88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-12 |