PKG., SDC ULTRA

Description of Event or Problem

INCORRECT DATA SAVED. IF TWO PATIENT ARE LOADED IN THE TO DO LIST, WHEN THE IMAGES ARE SAVED, THE INCORRECT PATIENT DATA IS BEING SAVED WITH THE IMAGES. EXAMPLE: PATIENT ONE'S PICTURES ARE GETTING PATIENT 2'S DATA.

Additional Manufacturer Narrative

AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 07/01/2006 TO 07/01/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED UNDER EXEMPTION (B)(4). THERE ARE 1 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE LMB.