BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8MM TI LOCKING SCREW

    MDR report key: 2121398 · Received June 7, 2011

    Report

    Report Number
    2520274-2011-00188
    Event Type
    Injury
    Date Received
    June 7, 2011
    Report Date
    May 20, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    K994187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. G1, H4: SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER OR A 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

    SCREW WAS NOTED TO BE BACKING OUT OF THE PLATE. FOLLOW UP X-RAY SHOWED SCREW AND LOCKING SCREW WERE BACKING OUT. REMOVED SCREW THAT WAS BACKING OUT AND REPLACED WITH A WIDER DIAMETER SCREW AND LOCKING SCREW. THIS IS THE SECOND OF TWO REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.8MM TI LOCKING SCREW LOCKING SCREW KWP SYNTHES (USA) NA NI

    Patients

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