BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCREW, SELF-TAPPING ICS Ø4.5MM X 44MM 3.5MM HEX

    MDR report key: 3251411 · Received July 29, 2013

    Report

    Report Number
    0008031020-2013-00250
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PMA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE AFFECTED DEVICES WERE RECEIVED. THIS DEVICE WAS IDENTIFIED AS A CONCOMITANT PRODUCT AND DOES NOT SHOW ANY CORROSION MARK ON IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A UNION OF A HIP FRACTURE, OMEGA PLUS LAG SCREW AND PLATE WERE USED FOR FIXATION. DUE TO THE PATIENT HAVING (B)(6), IMPLANTS WERE REMOVED. WHEN IMPLANTS WERE REMOVED, WE SAW CORROSION WHERE LAG SCREW AND PLATE INTERSECTED AND DOWN THE BARREL. DR. NOTICED CORROSION AND WANTED IT TESTED FOR DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A UNION OF A HIP FRACTURE, OMEGA PLUS LAG SCREW AND PLATE WERE USED FOR FIXATION. DUE TO THE PATIENT HAVING MRSA IMPLANTS WERE REMOVED. WHEN IMPLANTS WERE REMOVED WE SAW CORROSION WHERE LAG SCREW AND PLATE INTERSECTED AND DOWN THE BARREL. DR. NOTICED CORROSION AND WANTED IT TESTED FOR DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354161 CORTICAL BONE SCREW, SELF-TAPPING ICS Ø4.5MM X 44MM 3.5MM HEX IMPLANT HWC STRYKER TRAUMA SELZACH N03868

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention