BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 30MM

    MDR report key: 2924547 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00092
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS A DUPLICATE OF PER (B)(4). THIS EVENT HAS BEEN REPORTED UNDER MFR REPORT FOR REPORT #9616680-2012-00780.

    Additional Manufacturer Narrative · 1

    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 THE PATIENT HAS ADVERSE LOCAL TISSUE REACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29215 LRG TAP PRI MOD NCK 0DEG 30MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 33271001

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other