BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIB HOOK

    MDR report key: 2738038 · Received September 4, 2012

    Report

    Report Number
    2520274-2012-01758
    Event Type
    Injury
    Date Received
    September 4, 2012
    Report Date
    August 7, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. PRODUCT DEVELOPMENT REVIEWED THE EVENT, INSTRUCTIONS FOR CLEANING AND STERILIZATION ARE PROVIDED ON THE DEVICE PACKAGE INSERT; IT CAN NOT BE DETERMINED IF THE DEVICE HAD BEEN CLEANED AND STERILIZED CORRECTLY. THE RISK ASSESSMENT FOR VEPTR IMPLANTS WAS REVIEWED AND ADEQUATELY ADDRESSES THE COMPLAINT EVENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH VEPTR II CONSTRUCT ON AN UNK DATE. PT DEVELOPED SMALL SKIN BREAKDOWN AND SERIOUS DRAINAGE FROM VEPTR ROD AT THE CRANIAL ASPECT OF GROWING ROD. PT REPORTEDLY WAS HAVING FEVER AND CHILLS FOR THE PAST 2 DAYS SINCE (B)(6) 2012. PT'S HARDWARE HAS BEEN IN PLACE FOR MANY YEARS BUT NOW IS PRESENTED WITH INFECTION. PT WAS RETURNED TO HE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. SURGEON REMOVED ONE LEFT VEPTR ROD AND SEVERAL HOOKS. THE SCREWS REMAIN IMPLANTED IN THE PT. PT WAS REVISED WITH TREATMENT FOR THE INFECTION AND NEW HARDWARE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIB HOOK RIB HOOK MDI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention ROD