BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTISKNEE CUTTING GUIDE - STRYKER

    MDR report key: 1624858 · Received February 19, 2010

    Report

    Report Number
    3005738134-2010-00014
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 17, 2008
    Report Date
    February 10, 2010
    Manufacturer
    OTISMED CORP
    Product Code
    OOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PRODUCTION RECORDS, PHOTOS. RESULTS: SEGMENTATION GOOD, PRE-OPERATIVE PLANNING SHOTS ARE APPROPRIATE, IMPLANT SIZING AND ORIENTATION CORRECT. CONCLUSION: INDICATES UNAUTHORIZED IMPLEMENTATION OF FILE TRANSFER MACRO. CHANGE IMPLEMENTED WITHOUT FULL VALIDATION OF EFFECT OF CHANGE. FAILURE TO FOLLOW ESTABLISHED PROTOCOL.

    Description of Event or Problem · 1

    INITIAL PLACEMENT OF THE FEMUR GUIDE SEEMED OK. CUTS PERFORMED. SLIGHTLY VARUS AND EXTERNALLY ROTATED, A THIN CUT, BUT SEEMED ADEQUATE. AFTER REMOVAL, CUT SEEMED TO BE EXCESSIVE ON THE POSTERIOR MEDIAL SIDE RESULTING IN MEDIAL LAXITY. THE CUTS JUST DID NOT SEEM BALANCED. DISTAL FEMUR PIN HOLES SEEMED TO BE PLACED POSTERIORLY MORE THAN USUAL. TIBIAL CUTS WERE DONE WITHOUT INCIDENT. MD IS AWARE OF CHANGES IN GUIDES RECENTLY PRODUCED. SINCE HE IS NOT DELIGHTED WITH THE RESULT IN THIS CASE, HE WANTS TO KNOW HOW THE "DIFFERENCES" WOULD HAVE AFFECTED THE SURGERY HE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTISKNEE CUTTING GUIDE - STRYKER NONE OOG OTISMED CORP NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other