BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-DRILLING HALF PIN APEX 4MM, 120 X 30MM

    MDR report key: 2924462 · Received December 14, 2012

    Report

    Report Number
    8031020-2012-00298
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JDW
    PMA / PMN Number
    K861766
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING SURGERY FOR THE EX.FIX, THE SURGEON INSERTED THE APEX PIN. HOWEVER THE TIP OF THE APEX PIN WAS BENT ON THE THREAD PART. THEREFORE, THE SURGEON CHANGED THE APEX PIN TO ANOTHER PIN. THE PT WAS A YOUNG MAN AND BONE QUALITY WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF-DRILLING HALF PIN APEX 4MM, 120 X 30MM IMPLANT JDW STRYKER OSTEOSYNTHESIS SELZACH NA Z08423

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other