FDA Adverse Event Injury Summary report: N

REFLECTION

MDR report key: 641560 · Received October 18, 2005

Report

Report Number
1020279-2005-00354
Event Type
Injury
Date Received
October 18, 2005
Date of Event
September 25, 2004
Report Date
October 4, 2005
Manufacturer
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
Product Code
EJK
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
HI, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 REFLECTION CONSTRAINT LINER EJK SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. UNK 04EM00536

Patients

Seq Age Sex Outcome Treatment
1 58 YR Hospitalization| R