BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN TIBIAL ALIGN GUIDE SPIKE ARM

    MDR report key: 4173569 · Received August 7, 2014

    Report

    Report Number
    1822565-2014-00960
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PIN BROKE OFF THE SPIKE ARM DURING SURGERY. NO PIECE WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463170 NEXGEN TIBIAL ALIGN GUIDE SPIKE ARM LXH ZIMMER, INC. 61142779

    Patients

    Seq Age Sex Outcome Treatment
    1