BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23MM CALCAR BODY/BOLT (+10) COMPONENT LEVEL 9002

    MDR report key: 2052420 · Received March 16, 2011

    Report

    Report Number
    9616680-2011-00128
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LWJ
    PMA / PMN Number
    K050138
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DR. REMOVED TFN NAIL THAT HAD FAILED. DR. PLACED MOD RESTORATION 155 STEM PRESS-FIT. TRIED TO PLACE ABOVE IMPLANT MOD RESTORATION CALCAR BODY BUT WAS UNABLE TO SEAT IMPLANT. TRIMMED MORE BONE AND STILL UNABLE TO SEAT IMPLANT. CHANGED TO CONE BODY IMPLANT. CONE BODY SEATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 23MM CALCAR BODY/BOLT (+10) COMPONENT LEVEL 9002 IMPLANT LWJ STRYKER ORTHOPAEDICS CORK NA T84632CA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention