BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CANCELLOUS BONE SCREWSELF-TAPPING 12MM

    MDR report key: 3130614 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02804
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING AN ANTERIOR FUSION PROCEDURE ON (B)(4) 2013, THE ANTERIOR CERVICAL LOCKING PLATE SCREW PLACED ON THE RIGHT SIDE IN THE MOST CRANIAL PLATE HOLE DID NOT LOCK TO THE PLATE. THE SCREW PASSED COMPLETELY THROUGH THE PLATE HOLE AND WAS NOT AGREEABLE TO REMOVAL. IT WAS LEFT IN THE BONE. THERE WAS NO EXTENSION OF SURGERY TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231654 4.5MM TI CANCELLOUS BONE SCREWSELF-TAPPING 12MM KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR