BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOFIX LRS CLAMPS AND SCREW

    MDR report key: 334575 · Received May 23, 2001

    Report

    Report Number
    9680825-2001-00006
    Event Type
    Malfunction
    Date Received
    May 23, 2001
    Report Date
    May 23, 2001
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON APPLIED AN LRS FIXATOR TO THE PATIENT TO PERFORM A 5CM FEMORAL LENGTHENING. DURING LENGTHENING THE LRS CLAMPS BROKE, ONE SCREW BENT AND THEN BROKE ON ITS REMOVAL. IT WAS REPLACED WITH A NEW ONE.

    Description of Event or Problem · 1

    THE SURGEON APPLIED AN LRS FIXATOR TO THE PT TO PERFORM A 5 CM FEMORAL LENGTHENING. DURING LENGTHENING THE LRS CLAMPS BROKE, ONE SCREW BENT AND THEN BROKE ON ITS REMOVAL. IT WAS REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24039 ORTHOFIX LRS CLAMPS AND SCREW EXTERNAL FIXATION JEC ORTHOFIX SRL CODE 50540, 50540, 10165 C11, 008, MA003

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR