BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2041956 · Received March 29, 2011

    Report

    Report Number
    8030965-2011-00129
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 10, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    EZX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510 (K)# WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    ALL LOCKING SCREWS WERE TIGHTENED WITH A TORQUE LIMITER. DURING REVISION SURGERY, FOR AN UNKNOWN REASON, TWO LOCKING SCREWS BECAME JAMMED WITH THE PLATE AND WERE DIFFICULT TO REMOVE. PRESSURE WAS APPLIED TO THE SCREWDRIVER TIP, CAUSING THE SCREWDRIVER TIP TO TWIST AND DEFORMATION OF THE SCREW RECESS. THE PLATE AND SCREWS WERE REMOVED. THIS IS THE 9TH OF 9 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI SYNMESH EZX SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| END RING| PLATE