BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT

    MDR report key: 2883460 · Received November 14, 2012

    Report

    Report Number
    3005738134-2012-00033
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS ALAMEDA
    Product Code
    MBH
    PMA / PMN Number
    K110533
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON COMMENTED THAT FEMUR BLOCK DID NOT FIT. HE DID NOT TRUST BLOCKS. USED TRADITIONAL INSTRUMENTS. UPSET ABOUT THE SHORT TIME BETWEEN PLAN APPROVAL AND SURGERY DATE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT INSTRUMENT MBH STRYKER ORTHOPAEDICS ALAMEDA NA 12262014

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other