FDA Adverse Event
Other
Summary report: N
MEDTRONIC
MDR report key: 6116249
·
Received November 18, 2016
Report
- Report Number
- MW5066188
- Event Type
- Other
- Date Received
- November 18, 2016
- Date of Event
- November 8, 2016
- Report Date
- November 10, 2016
- Manufacturer
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Product Code
- HBE
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING A CRANIOTOMY A PIECE OF DRILL BIT BROKE OFF AND REMAINS IN THE PATIENT. RETRIEVAL WOULD BE MORE RISKY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764899 | MEDTRONIC | DISSECTING TOOL | HBE | MEDTRONIC POWERED SURGICAL SOLUTIONS | REF F2/8TA23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |