BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 30MM

    MDR report key: 2821501 · Received October 23, 2012

    Report

    Report Number
    9616680-2012-00923
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR DUE TO HOSPITAL POLICY. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS: 2249697-2012-02029.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 0DEG 30MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 23282101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention