BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT NECK

    MDR report key: 2912790 · Received January 8, 2013

    Report

    Report Number
    9616680-2013-90068
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 3, 2010
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS CONTACTED REGARDING THE RECALL. PT COMPLETED MRI, X-RAYS AND BLOOD TEST. PT REPORTS THAT COBALT LEVELS WERE HIGH. PT WILL RE-TEST IN SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10060 UNKNOWN LEFT NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other