MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-24 for TREPHINE 260-801-837 manufactured by Bicon, Llc.
[98539042]
Attempts were made to gather more information, but the doctor was openly hostile and did not provide any requested information but did say that the patient did not have any of the pieces inhaled.
Patient Sequence No: 1, Text Type: N, H10
[98539043]
A 3. 75mm trephine reportedly shattered during the patient procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1223843-2018-00001 |
| MDR Report Key | 7216376 |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-24 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-01-17 |
| Date Added to Maude | 2018-01-24 |
| 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 | MR. RICHARD WU |
| Manufacturer Street | 501 ARBORWAY |
| Manufacturer City | BOSTON MA 02130 |
| Manufacturer Country | US |
| Manufacturer Postal | 02130 |
| Manufacturer Phone | 6175244443 |
| Manufacturer G1 | BICON, LLC |
| Manufacturer Street | 501 ARBORWAY |
| Manufacturer City | BOSTON MA 02130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TREPHINE |
| Generic Name | BUR |
| Product Code | EJL |
| Date Received | 2018-01-24 |
| Returned To Mfg | 2018-01-18 |
| Model Number | 260-801-837 |
| Catalog Number | 260-801-837 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BICON, LLC |
| Manufacturer Address | 501 ARBORWAY BOSTON MA 02130 US 02130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-24 |