BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSS INSTRUMENTS LTD

    MDR report key: 3229927 · Received July 10, 2013

    Report

    Report Number
    MW5030878
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 10, 2013
    Manufacturer
    BOOS INSTRUMENTS, LTD
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, AN ANTERIOR CERVICAL FUSION WAS PERFORMED. WHILE INSERTING THE DISTRACTOR PIN, INTO THE SURGICAL SITE, IT WAS NOTED BY THE SURGEON THAT THE TIP OF THE PIN HAD BROKEN OFF INTO THE SITE. THE SURGEON ATTEMPTED TO REMOVE THE BROKEN END OF THE TIP, SEVERAL TIMES, BUT WAS NOT ABLE TO DO SO WITHOUT CAUSING FURTHER DAMAGE TO THE SURGICAL SITE. THE PIN WAS MEASURED AGAINST AN INTACT PIN AND THE SURGEON WAS INFORMED THAT THE TIP THAT HAD BROKEN OFF WAS APPROXIMATELY 10MM IN LENGTH. THE SURGEON DECIDED TO INTENTIONALLY LEAVE THE TIP IN THE SURGICAL SITE AND THE PATIENT WAS INFORMED POST-OPERATIVELY. REASON FOR USE: DISC FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315386 BOSS INSTRUMENTS LTD 14MM STERILE DISTRACTION SCREWS HWC BOOS INSTRUMENTS, LTD 73-2592-S5 1418D002

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention