BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 8DEG 34MM

    MDR report key: 2910794 · Received January 8, 2013

    Report

    Report Number
    9616680-2013-90051
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORD) WAS REQUESTED BUT NOT MADE AVAILABLE AS PER HOSPITAL PROTOCOL. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STRYKER IMPLANT REMOVED DUE TO ALTR. REPLACED WITH ZIMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9889 LRG TAP PRI MOD NCK 8DEG 34MM IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA 25519602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention