MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-15 for CARBIDE * ZB 104 manufactured by Microaire Surgical Instruments, Llc.
[3267613]
Dental drill burr (zb 104) broke during case. The drill tip was sucked into canisters. Drill tip not found. X-ray ordered for chest and right mandible. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3079663 |
| MDR Report Key | 3079663 |
| Date Received | 2013-04-15 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-04-03 |
| Report Date | 2013-04-15 |
| Date Reported to FDA | 2013-04-15 |
| Date Reported to Mfgr | 2013-04-26 |
| Date Added to Maude | 2013-04-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | CARBIDE |
| Generic Name | DRILL, BURR |
| Product Code | HTT |
| Date Received | 2013-04-15 |
| Model Number | * |
| Catalog Number | ZB 104 |
| Lot Number | 0113214852 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROAIRE SURGICAL INSTRUMENTS, LLC |
| Manufacturer Address | 1641 EDLICH DRIVE CHARLOTTESVILLE VA 22911 US 22911 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-15 |