BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOFIX STANDARD CD MODULE

    MDR report key: 447548 · Received February 11, 2003

    Report

    Report Number
    2183449-2003-00021
    Event Type
    Injury
    Date Received
    February 11, 2003
    Date of Event
    January 28, 2003
    Report Date
    February 7, 2003
    Manufacturer
    ORTHOFIX INC.
    Product Code
    JEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002 THE PATIENT UNDERWENT AN HTO PROCEDURE AND THE DOCTOR APPLIED AN EXTERNAL FIXATOR FOR TREATMENT. IN 2003 THE PATIENT PRESENTED AT FOLLOW-UP WITH PREMATURE CONSOLIDATION OF THE OSTEOTOMY SITE. THE DOCTOR NOTICED THAT THE COMPRESSION/DISTRACTION MODULE ON THE EXTERNAL FIXATOR WAS NOT FUNCTIONING CORRECTLY (WOULD NO LONGER MAINTAIN DISTRACTION LEVEL), AND THE PATIENT MENTIONED THAT THEY HAD HEARD A NOISE FROM THE CD MODULE A COUPLE OF WEEKS AGO. THE DOCTOR TOOK THE PATIENT BACK INTO THE OR 2 DAYS LATER AND PERFORMED A REOSTEOTOMY AND REPLACED THE BROKEN CD MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOFIX STANDARD CD MODULE EXTERNAL FIXATION JEC ORTHOFIX INC. 10008 MC003

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention