BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KMEDIC LAMINA SPREADER 10 1/2" FLAT BLADE

    MDR report key: 1638279 · Received March 16, 2010

    Report

    Report Number
    3005236665-2010-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 24, 2010
    Manufacturer
    KMEDIC EUROPE GMBH
    Product Code
    FFO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TIP OF THE HANDLE BROKE OFF; IT WON'T HOLD IN OPEN POSITION. THE CUSTOMER ALSO REPORTS THAT THE ISSUE WAS DISCOVERED DURING A SURGICAL PROCEDURE WHEN THE DEVICE WOULD NOT HOLD TENSION. THERE WAS NO PIECE FOUND, AND PER CUSTOMER, THERE'S THE POSSIBILITY THAT THE END OF DEVICE IS MISSING BECAUSE IT DID NOT FIT FULLY INTO THE RACHET BAR. NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KMEDIC LAMINA SPREADER 10 1/2" FLAT BLADE LAMINA SPREADER FFO KMEDIC EUROPE GMBH NA 04/4

    Patients

    Seq Age Sex Outcome Treatment
    1