BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI RIB SLEEVE-SIZE 8 220MM RADIUS

    MDR report key: 1735805 · Received June 17, 2010

    Report

    Report Number
    2530088-2010-00095
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    X-RAYS TAKEN FOR PATIENT'S SCHEDULED LENGHTENING SHOWED A BENT RIB SLEEVE. DURING PLANNED LENGTHENING PROCEDURE ON (B)(6) 2010, RIB SLEEVE CLARIFIED AS BROKEN, NOT BENT. VEPTR I WAS REMOVED. SURGEON RE-INSTRUMENTED PATIENT TO VEPTR II IN THE SAME LOCATION. SURGEON NOTED THAT THE RIB SLEEVE BREAKAGE MAY HAVE RESULTED FROM THE PREVIOUS SIX MONTH EXPANSION PROCEDURE ON (B)(6) 2009. THE RIB SLEEVE SIZE WAS HYPER-EXTENDED BEYOND THE HOLES. ALTHOUGH DISTRACTION LOCKS WERE INSERTED INTO THE RIB SLEEVE, BECAUSE IT WAS HYPER-EXTENDED BEYOND THE HOLES, THE DISTRACTION LOCK DID NOT COME IN CONTACT WITH THE LUMBAR EXTENSION TO LOCK THE TWO DEVICES TOGETHER. THE CONSTRUCT BEGAN TO MOVE AND EVENTUALLY CAUSED THE BOTTOM RAIL OF THE RIB SLEEVE TO BREAK OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI RIB SLEEVE-SIZE 8 220MM RADIUS VEPTR IMPLANTS MDI SYNTHES BRANDYWINE NA 4824042

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR DISTRACTION LOCK| LUMBAR EXTENSION