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