FDA Adverse Event
Injury
Summary report: N
EBA2
MDR report key: 4848125
·
Received June 11, 2015
Report
- Report Number
- 3009530665-2015-00001
- Event Type
- Injury
- Date Received
- June 11, 2015
- Date of Event
- May 15, 2015
- Report Date
- June 8, 2015
- Manufacturer
- CITIEFFE S.R.L.
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IMPLANT BREAKAGE OF CEPHALIC SCREW ON INTRAMEDULLARY NAIL FOR REVERSE OBLIQUE TROCHANTERIC FRACTURE. MFR # 3003249380-2015-00001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381010 | EBA2 | PROXIMAL FEMORAL NAIL CEPHALIC SCREW | HSB | CITIEFFE S.R.L. | EBA-7110 | 0PD017990000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |