BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NECK

    MDR report key: 2922530 · Received January 15, 2013

    Report

    Report Number
    9616680-2013-90126
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    June 23, 2010
    Report Date
    December 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO IS REC'D IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT: ALLEGEDLY, AFTER IMPLANTATION OF THE DEVICE, THE PT BEGAN EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT. IT IS ALLEGED THAT THE PT WILL REQUIRE REVISION SURGERY TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22530 UNKNOWN NECK IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other