BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI ALLOY 6.35 ROD

    MDR report key: 2403480 · Received January 8, 2012

    Report

    Report Number
    0002242816-2012-00003
    Event Type
    Injury
    Date Received
    January 8, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 9, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 2 MDRS INVOLVED IN THE SAME EVENT. PLEASE SEE MDR NUMBERS:2242816-2012-0002.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED TO REMOVE A BROKEN TI ALLOY 6.35 ROD. ADDITIONALLY, DURING THE PROCEDURE TWO TORQUE WRENCHES WOULD NOT FUNCTION. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI ALLOY 6.35 ROD TI ALLOY 6.35 ROD KWQ EBI, LLC N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention