BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOFIX TIB-HEAD-PL MED PROX 4HO TI

    MDR report key: 2211309 · Received August 3, 2011

    Report

    Report Number
    8030965-2011-00521
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    April 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A CLINIC IN (B)(6) REPORTED: PT IMPLANTED WITH TOMOFIX PLATE ON (B)(6)-2011 RETURNED TO SURGEON FOR POST OP F/U VISIT ON AN UNK DATE: EVERYTHING WAS NORMAL AT THAT TIME. PT RETURNED TO SURGEON ON (B)(6) 2011 AND AN X-RAY SHOWED THE PLATE WAS BROKEN, NO SCREWS WERE BROKEN. SURGEON REMOVED THE PLATE AND SCREWS ON AN UNK DATE AND REVISED THE PT TO ANOTHER TOMOFIX PLATE WITH LONGER SCREWS. PT IS NOW ALMOST HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOMOFIX TIB-HEAD-PL MED PROX 4HO TI TOMOFIX TIB-HEAD-PL HRS SYNTHES GMBH 2647547

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR SCREW