FDA Adverse Event
Malfunction
Summary report: N
ORTHOLOCK EX-PIN 3X110
MDR report key: 4202228
·
Received October 13, 2014
Report
- Report Number
- 4202228
- Event Type
- Malfunction
- Date Received
- October 13, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 13, 2014
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- HAW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT UNDERGOING SURGERY, IDENTIFIED THAT NAVIGATION PIN WAS BROKEN. COULD NOT BE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647519 | ORTHOLOCK EX-PIN 3X110 | NAVIGATION PIN | HAW | STRYKER INSTRUMENTS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |