FDA Adverse Event
Injury
Summary report: N
ACCORD
MDR report key: 1933461
·
Received December 20, 2010
Report
- Report Number
- 1020279-2010-00365
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- November 22, 2010
- Report Date
- December 20, 2010
- Manufacturer
- SMITH & NEPHEW, ORTHOPEDICS
- Product Code
- KTT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGERY WAS DELAYED DUE TO THE SURGEON NOT BEING ABLE TO PROPERLY TIGHTEN THE CABLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCORD | TENSIONER | KTT | SMITH & NEPHEW, ORTHOPEDICS | OR71360020 | 09CM01660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR |