BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI RIB HOOK

    MDR report key: 2261174 · Received September 20, 2011

    Report

    Report Number
    2530088-2011-00525
    Event Type
    Injury
    Date Received
    September 20, 2011
    Report Date
    August 22, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 RETURNED.

    Description of Event or Problem · 1

    PT STATUS POST VEPTR IMPLANTATION ON (B)(6)-2011 RETURNED TO SURGEON AND PRESENTED WITH AN INFECTION. SURGEON REMOVED THE HARDWARE (B)(6) 2011 ON THE LEFT SIDE OF PT AND PERFORMED AN I & D PROCEDURE AND CLOSED THE PT. SURGEON SCHEDULED TO REVISE THE PT ON (B)(6)-2011. A TOTAL OF EIGHT DEVICES WERE REMOVED. THIS IS SEVEN OF EIGHT REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR S-HOOK| CAP| DISTRACTION LOCK| CONNECTOR EXTENSION