BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLOUS SCREW 4.0 X 18 MM

    MDR report key: 1252815 · Received December 4, 2008

    Report

    Report Number
    8031020-2008-00205
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K972323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE REPORTED ON SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING RECON PLATE SURGERY, THE SURGEON USED THE CORTICAL SCREWS. HOWEVER, BECAUSE THE NUMBER OF CORTICAL SCREW HAD BECOME INSUFFICIENT, THE SURGEON USED CANCELLOUS SCREW FOR A SUBSTITUTE. THE SURGEON TRIED TO INSERT THE CANCELLOUS SCREW INTO THE ULNA, THEN THE SCREW HEAD OF THE CANCELLOUS SCREW BROKE AND THE SURGEON COULD NOT REMOVE THE SCREW SHAFT (ABOUT 13 MM). THE SURGEON IS PLANNING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLOUS SCREW 4.0 X 18 MM IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA P08629

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention