BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTISKNEE CUTTING GUIDE - BIOMET - RIGHT

    MDR report key: 1624877 · Received February 19, 2010

    Report

    Report Number
    3005738134-2010-00021
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    March 20, 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: SEGMENTATION REVIEW. RESULTS: SEGMENTATION REVIEW WAS CORRECT AND PERFORMED ACCORDING TO WORK INSTRUCTIONS. CONCLUSION: NO FAILURE, PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIBIA CUT WAS THICKER THAN REQUIRED. DOCTOR FELT THE CUT WAS ABOUT 4MM TOO MUCH. NEEDED TO USE A 16MM LINER TO FINISH THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other