BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTEX SCREW S.T.

    MDR report key: 1062180 · Received June 13, 2008

    Report

    Report Number
    8031020-2008-00041
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K972323
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING T-BUTTRESS PLATE SURGERY, THE SURGEON INSERTED THE SCREW. HOWEVER, THE LENGTH OF SCREW USED WAS LONG AND THE SURGEON REMOVED THE SCREW. THE SURGEON FOUND SOME METAL SHAVING FROM THE SCREW. THE METAL SHAVING WERE RETRIEVED FROM THE WOUND. THE SURGEON CHANGED THE SCREW TO A NEW SCREW AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTEX SCREW S.T. IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA K06568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other