BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLINE SELF DRILLING SCREW 12MM, TI

    MDR report key: 2233380 · Received September 2, 2011

    Report

    Report Number
    1526439-2011-00154
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    October 4, 2011
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    KWQ
    PMA / PMN Number
    K052552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BREAKAGE OF THE SCREW IS LIKELY RELATED TO THE APPLICATION OF ATYPICAL FORCE DURING INSERTION, HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED FOR EVALUATION. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT THE HEAD OF SCREW BROKE OFF THE SHAFT DURING INSERTION INTO THE CERVICAL PLATE. BODY OF THE SCREW WAS LEFT IN VIVO AND THE FRAGMENT REMOVED FROM THE SITE. THERE WAS NO ADVERSE OUTCOME AS A RESULT OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYLINE SELF DRILLING SCREW 12MM, TI SURGICAL FIXATION DEVICE KWQ DEPUY RAYNHAM AFNCK9

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR