FDA Adverse Event
Injury
Summary report: N
TARGETER SYSTEM
MDR report key: 1062897
·
Received June 19, 2008
Report
- Report Number
- 1020279-2008-00184
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 5, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON USING TARGETER SYSTEM FOR 3.5 MEDIAL-DISTAL PLATE; PLATE WOULD NOT SLIDE PERCUTANEOUSLY ON TARGETER - TIP OF PLATE GETTING CAUGHT ON SOFT TISSUE. OR TIME EXTENDED 45 MINUTES. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGETER SYSTEM | 3.5 MEDIAL-DISTAL TIBIAL LOCKING PLATE | HRS | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other |