BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING DRIVER FOR CSLP

    MDR report key: 1790148 · Received August 3, 2010

    Report

    Report Number
    1719045-2010-00213
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING AN ACDF AT C6-C7, ONE OF THE FOUR BLADES ON THE LOCKING DRIVER FOR CSLP BROKE OFF IN THE HEAD OF THE SCREW. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN TIP AND DID NOT REMOVE THE SCREW. BROKEN DRIVER TIP AND SCREW LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING DRIVER FOR CSLP LOCKING DRIVER LXH SYNTHES MONUMENT NA 1776779

    Patients

    Seq Age Sex Outcome Treatment
    1 NI