FDA Adverse Event
Injury
Summary report: N
INTERTAN
MDR report key: 1012679
·
Received March 12, 2008
Report
- Report Number
- 1020279-2008-00080
- Event Type
- Injury
- Date Received
- March 12, 2008
- Report Date
- March 6, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SURGERY WAS EXTENDED BY 60 MINUTES DUE TO THE DISTAL SCREW GUIDE NOT LINING UP OFF THE JIG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERTAN | INTERNAL FIXATION - NAIL | JDS | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | 08AM23074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |