BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT NECK

    MDR report key: 2860097 · Received December 4, 2012

    Report

    Report Number
    9616680-2012-01261
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    October 1, 2010
    Report Date
    November 19, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING SOME SORENESS. DURING EARLY OCTOBER PATIENT HAD BLOOD WORK DONE. THE BLOOD WORK RESULTS SHOW ELEVATED COBALT LEVELS. PATIENT ALSO STATES THAT HE HAD AN MRI DONE IN EARLY NOVEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT NECK IMPLANT KWL STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other