BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOFIX TIB-HEAD-PL MED PROX 4HO TI

    MDR report key: 2251131 · Received September 13, 2011

    Report

    Report Number
    8030965-2011-00611
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K023941
    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.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(6) INDICATES THE FOLLOWING: SIX MONTHS POST OPERATIVELY THE TOMOFIX WAS FOUND BY X-RAY TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOMOFIX TIB-HEAD-PL MED PROX 4HO TI TOMOFIX TIB-HEAD-PL MED PROX 4HO TI KTT SYNTHES GMBH 2699289

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCREWS