BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEPTR RIB SLEEVE

    MDR report key: 2559514 · Received May 1, 2012

    Report

    Report Number
    2530088-2012-00239
    Event Type
    Injury
    Date Received
    May 1, 2012
    Report Date
    April 2, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE REPORTED AS 2008 OR EARLIER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR PART NUMBER OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH VEPTR, RIB TO RIB CONSTRUCT IN 2008 OR EARLIER. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REVISION SURGERY. X-RAY FILMS TAKEN IN 2008 SHOWED THAT A DISTRACTION LOCK WAS NOT USED TO ATTACH THE VEPTR RIB SLEEVE AND THE RIB HOOK. THE VEPTR RIB SLEEVE BECAME DISENGAGED FROM THE SUPERIOR RIB HOOK. SURGEON REVISED PT BY RECONNECTING THE RIB SLEEVE AND RIB HOOK AND ADDING A DISTRACTION LOCK. THE HARDWARE REMAINS IMPLANTED IN THE PT. THIS IS THE 1ST OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEPTR RIB SLEEVE MDI SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention RIB HOOK| RIB HOOK