BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL RONG 9 SLIGHT-CVD 3MM

    MDR report key: 3251045 · Received July 23, 2013

    Report

    Report Number
    2523190-2013-00047
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    February 19, 2013
    Report Date
    July 22, 2013
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HTX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH # (B)(4), INITIALLY REPORTS A SCREW FROM A LESKELL RONGUER CAME LOOSE DURING SURGERY CAUSING EQUIPMENT TO COME APART. NOT NOTED IF ANY INJURY OR PT CONTACT. INCIDENT OCCURRED. ON (B)(6) 2013 CUSTOMER REPORTS PROCEDURE WAS LEFT HIP REPLACEMENT, X-RAY DONE CONFIRMS NO PARTS SEEN IN PT. ON (B)(6) 2013 CUSTOMER REPORTS CONFIRM NO HARM TO THE PT AND THEY SUSPECT THE SCREW WAS MISSING PRIOR TO THE PROCEDURE AND WAS NOT NOTICED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342040 LEKSELL RONG 9 SLIGHT-CVD 3MM NONE HTX INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR