BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINK(R) MP(R) NECK

    MDR report key: 2097462 · Received May 3, 2011

    Report

    Report Number
    9610548-2011-00012
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 21, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDI
    PMA / PMN Number
    K955296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PROVIDED INFO OF THE X-RAY IMAGES, WE EXCLUDE A DEVICE FAILURE. THE USER CHOSE A SHORT NECK SEGMENT IN COMBINATION WITH SPACERS, WHICH IS NOT ALLOWED. THIS INFO COULD BE FOUND IN OUR SURGICAL TECHNIQUE AS WELL AS IN OUR IMPLANT AND INSTRUMENTS MANUAL.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED; UNDETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PT COMPLAINED OF PAIN AND THE RECENT X-RAYS REVEALED A SCREW STICKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINK(R) MP(R) NECK HIP COMPONENT JDI WRIGHT MEDICAL TECHNOLOGY, INC. 172-945/58 0903130169

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R