BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITRAX C-TAPER SLEEVE +10MM

    MDR report key: 2020515 · Received February 16, 2011

    Report

    Report Number
    9616680-2011-00070
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWL
    PMA / PMN Number
    K883179
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THEY WENT TO IMPACT THE UNIPOLAR HEAD WITH THE ADJUSTMENT SLEEVE INSIDE THE HEAD. TESTED A NUMBER OF TIMES TO SEE IF THE TAPER WOULD ENGAGE AND IT WOULD NOT. HAD TO USE ANOTHER C TAPER UNIPOLAR SLEEVE +10MM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNITRAX C-TAPER SLEEVE +10MM IMPLANT KWL STRYKER ORTHOPAEDICS CORK NA 34750302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other