BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS DISTAL RESECTION GUIDE LT

    MDR report key: 1951281 · Received December 14, 2010

    Report

    Report Number
    2249697-2010-01730
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2010-01729.

    Description of Event or Problem · 1

    THE ALLEGED EVENT HAS BEEN REPORTED BY MRS. (B)(6), DISTRIBUTOR FROM (B)(4): THE DEVICES WERE JAMMED INTO THE GUIDES DURING A TOTAL KNEE PROSTHESIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS DISTAL RESECTION GUIDE LT INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other