BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT-

    MDR report key: 2873466 · Received November 15, 2012

    Report

    Report Number
    3005738134-2012-00035
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DOCTOR SAID PT'S TIBIA HAD WAY TOO MUCH VARUS - RIGHT SIDE, AND HAD TO ABORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT- INSTRUMENT MBH STRYKER ORTHOPAEDICS ALAMEDA NA 12262051

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other