BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA MID-STM #3 RT 160 W/PROX R

    MDR report key: 1053359 · Received May 28, 2008

    Report

    Report Number
    2249697-2008-00144
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    STRYKER ORTHOPAEDIC MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFORMATION, HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT PCA STEM FRACTURED AT THE HEAD/NECK JUNCTION, AND WAS REPLACED WITH A RESTORATION MODULAR STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MID-STM #3 RT 160 W/PROX R IMPLANT KWY STRYKER ORTHOPAEDIC MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention