FDA Adverse Event
Malfunction
Summary report: N
ORTHOFIX
MDR report key: 7435690
·
Received April 17, 2018
Report
- Report Number
- 7435690
- Event Type
- Malfunction
- Date Received
- April 17, 2018
- Date of Event
- March 30, 2018
- Report Date
- April 6, 2018
- Manufacturer
- ORTHOFIX INC.
- Product Code
- JDO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SCREWDRIVER TIP BROKE WHILE IMPLANTING SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278414 | ORTHOFIX | DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT | JDO | ORTHOFIX INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |