BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLANMECA INTRA X-RAY

    MDR report key: 3070464 · Received April 16, 2013

    Report

    Report Number
    MW5029853
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    PLANMECA USA
    Product Code
    EHD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PLANMECA INTRA X-RAY MFR DEFECT: SCISSOR ARM RETENTION PIN SHEARED OFF AT SUPPORT AXLE WHILE BEING EXTENDED HORIZONTALLY UNDER NORMAL USE. HAD MECHANICAL PIN FAILED DURING USE, THE FULL WEIGHT OF THE X-RAY TUBE HEAD WOULD HAVE SWUNG INTO THE FACE OF A PT WITH SERIOUS POTENTIAL FOR TRAUMATICALLY REMOVING TEETH ALONG SWING PATH WITH DIGITAL SENSOR, XCP AND BITE-TAB INSIDE PT'S MOUTH CAUSING ADD'L INTRA ORAL DAMAGE. MFR MAINTAINS THEY WILL NOT STAND BEHIND DEFECTIVE MECHANICAL PART OUTSIDE OF THEIR TWO YEAR WARRANTY FROM DATE OF MANUFACTURE. TECHNICIAN ADVISED PIN FAILURE OF SCISSOR ARM IS NOT UNCOMMON, THAT REPLACEMENT OF THE ENTIRE ARM IS RECOMMENDED OVER REPLACING THE DEFECTIVE PIN ALONE; SCISSOR ARM REPLACEMENT PART IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163866 PLANMECA INTRA X-RAY PLANMECA INTRA X-RAY EHD PLANMECA USA INTRA

    Patients

    Seq Age Sex Outcome Treatment
    1