MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-10 for H375R.31.023 FG ROUND-END TAPER CARBIDE 012840U0 manufactured by Brasseler Usa.
[178565519]
The doctor was preparing 2 crowns (25,26) and when using the h375r. 31. 023 bur, the bur bent and struck tooth 25 and fractured it. The doctor was not able to restore the tooth as it was 6mm subgingival. He extracted the tooth and placed an implant. The patient underwent an extra hour of oral sedation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032227-2020-00001 |
| MDR Report Key | 9687276 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-10 |
| 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 Contact | JOHN DETRES |
| Manufacturer Street | ONE BRASSELER BLVD |
| Manufacturer City | SAVANNAH, GA |
| Manufacturer Country | US |
| Manufacturer Phone | 8414522541 |
| Manufacturer G1 | BRASSELER USA |
| Manufacturer Street | ONE BRASSELER BLVD |
| Manufacturer City | SAVANNAH, GA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | H375R.31.023 FG ROUND-END TAPER CARBIDE |
| Generic Name | CARBIDE BUR |
| Product Code | EJL |
| Date Received | 2020-02-10 |
| Model Number | 012840U0 |
| Catalog Number | 012840U0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRASSELER USA |
| Manufacturer Address | ONE BRASSELER BLVD SAVANNAH, GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-10 |