FDA Adverse Event
Injury
Summary report: N
ASCEND
MDR report key: 3133755
·
Received May 23, 2013
Report
- Report Number
- 3004983210-2013-00009
- Event Type
- Injury
- Date Received
- May 23, 2013
- Date of Event
- December 7, 2011
- Report Date
- March 26, 2013
- Manufacturer
- TORNIER INC
- Product Code
- HSD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem · 1
POST OP, OTHER COMPLICATIONS, PERIPROSTHETIC FRACTURE, UNK COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229838 | ASCEND | NONE | HSD | TORNIER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |