BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE; DRIVER

    MDR report key: 2842736 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03325
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A LOCKING CAP ASSOCIATED WITH AN INTERVERTEBRAL FIXATION, L4 - L5, PROCEDURE. THE SURGEON TRIED TO LOOSEN THE LOCKING CAPS IN ORDER TO PLACE THEM AGAIN UPON OBSERVING THAT THE SCREW ON THE RIGHT SIDE OF THE L4 WAS SLIGHTLY DISPLACED IN A LATERAL DIRECTION. ACCORDING TO THE INSTRUCTION, HE TRIED TO REMOVE THE LOCKING CAP AT L5, TURNING IN A COUNTER DIRECTION MANY TIMES, AND ATTEMPTING TO USE DRIVERS, STRIKING THEM WITH A HAMMER (BREAKING BOTH DRIVERS); HOWEVER, IT NEVER LOOSENED. THE OTHER LOCKING CAP WAS SUCCESSFULLY LOOSENED AT THE L4. REPORTEDLY, THERE WAS NO PROBLEM WHILE PLACING THE LOCKING CAPS INITIALLY, AND IT WAS CONFIRMED THAT THEIR CROSS THREADS AND SCREW HEADS HAD NO IRREGULARITY DURING THE OPERATION. THIS IS REPORT #5 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE; DRIVER SPINE; DRIVER MNH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention