BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI RIB

    MDR report key: 1558377 · Received December 11, 2009

    Report

    Report Number
    2530088-2009-00245
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    November 24, 2009
    Report Date
    November 24, 2009
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED, SYNTHES IS UNABLE TO PROVIDE THE DATE OF MFR WITHOUT A LOT NUMBER OR DEVICE RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO LOT NUMBER WAS PROVIDED AND NO DEVICE WAS RETURNED. THE MFG RECORDS CANNOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A VEPTR II DISTRACTION PROCEDURE THE SURGEON INSERTED THE TI RIB HOOK AND WAS DISTRACTING THE DEVICE. THE DISTRACTOR BROKE ACROSS THE LOCK AND FRACTURED THE PT'S RIB. SURGEON REMOVED THE DEVICE AND INSTALLED ANOTHER RIB HOOK AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI RIB RIB HOOKS MDI SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Required Intervention