MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-09-08 for BRASSELER 859.36.010 016014U0 manufactured by Brasseler Usa.
[2171224]
Parts of the diamond coating on a bur had separated from the base, lodged in bone and 'required extensive surgery to remove the sections' from a pt. The bur was being used to go in alongside the tooth to remove something when the diamond coating separated from the bur. It took about an hour to remove two of the pieces with an endodontic explorer while the pt was still in the chair. There was one more piece (the tip) remaining in the pt. The pt is fully aware of its presence and possible complications. The doctor believes it will be inert.
Patient Sequence No: 1, Text Type: D, B5
[9514388]
The product involved in the event was returned. An investigation is currently in process. When the investigation is completed, the results will be reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1032227-2011-00005 |
| MDR Report Key | 2246652 |
| Report Source | 05,07 |
| Date Received | 2011-09-08 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-07-21 |
| Date Mfgr Received | 2011-08-12 |
| Date Added to Maude | 2011-09-15 |
| 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 | KENNETH JONES |
| Manufacturer Street | 1 BRASSELER BLVD. |
| Manufacturer City | SAVANNAH GA 31419 |
| Manufacturer Country | US |
| Manufacturer Postal | 31419 |
| Manufacturer Phone | 9129217501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRASSELER |
| Product Code | DZP |
| Date Received | 2011-09-08 |
| Returned To Mfg | 2011-08-25 |
| Model Number | 859.36.010 |
| Catalog Number | 016014U0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRASSELER USA |
| Manufacturer Address | SAVANNAH GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-08 |