FDA Adverse Event
Injury
Summary report: N
OTTO BOCK TUBE ADAPTER (TITANIUM 30MM ALUMINUM ALOE TUBE)
MDR report key: 30749
·
Received February 1, 1996
Report
- Report Number
- 30749
- Event Type
- Injury
- Date Received
- February 1, 1996
- Date of Event
- July 17, 1995
- Report Date
- July 24, 1995
- Manufacturer
- OTTO BOCK, ORTHOPEDIC INDUSTRY, INC.
- Product Code
- ISH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT WALKING ON LEG PROSTHESIS. THE TUBE ADAPTER COMPONENT OF PROSTHESIS BROKE. PT FELL FRACTURING HIP. SURGICAL REDUCTION AND INTERNAL FIXATION PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OTTO BOCK TUBE ADAPTER (TITANIUM 30MM ALUMINUM ALOE TUBE) | TUBE ADAPTER (TITANIUM 30MM ALUMINUM ALOE TUBE) | ISH | OTTO BOCK, ORTHOPEDIC INDUSTRY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R |