MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-24 for BOSS KERRISON * manufactured by Boss Instruments, Ltd.
[278778]
While using 1 millimeter boss kerrison during craniotomy the tip broke off. Unable to locate the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 439138 |
| MDR Report Key | 439138 |
| Date Received | 2003-01-24 |
| Date of Report | 2002-08-01 |
| Date of Event | 2002-06-19 |
| Report Date | 2002-08-01 |
| Date Reported to FDA | 2002-08-08 |
| Date Added to Maude | 2003-01-27 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | BOSS KERRISON |
| Generic Name | BONE PUNCH |
| Product Code | GXJ |
| Date Received | 2003-01-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 428074 |
| Manufacturer | BOSS INSTRUMENTS, LTD |
| Manufacturer Address | 1838 ELM HILL PIKE SUITE 119 NASHVILLE TN 37210 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-01-24 |