FDA Adverse Event
Injury
Summary report: N
SURESHOT TARGETING I
MDR report key: 2044500
·
Received April 7, 2011
Report
- Report Number
- 1020279-2011-00118
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- March 14, 2011
- Report Date
- April 7, 2011
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, INC.
- Product Code
- OLO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CORRECT CODE IS OLO; THIS CODE IS NOT LISTED IN OUR MDR REPORTING DATABASE. WE HAVE MADE A REQUEST TO OUR VENDOR FOR THIS CODE TO BE UPLOADED.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGERY WAS DELAYED DUE TO AN ERROR MESSAGE ON THE INTERFACE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESHOT TARGETING I | TRAUMA INTERFACE | OLO | SMITH & NEPHEW ORTHOPAEDICS, INC. | 71692802 | ACA 400 4008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |