BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVSPINE-EXP-HEADSCR Ø4 SELF-DRILL L14

    MDR report key: 2882490 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04256
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A SURGEON IN THE (B)(6) REPORTED: SURGEON INSERTED A SCREW AT THE WRONG ANGLE INTO A PLATE. SURGEON TRIED TO REMOVE THE SCREW AND IT JUST SPUN INSIDE THE PLATE. SURGEON DID NOT TRY TO USE THE REMOVAL TOOL AND THE SCREW REMAINS IN THE PLATE. SURGEON DID INSERT ANOTHER SCREW, LOCKING SCREW, INTO THE PLATE AND COMPLETED THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERVSPINE-EXP-HEADSCR Ø4 SELF-DRILL L14 CERVSPINE-EXP-HEADSCREW KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW,PLATE