BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX EXPERT DC INTRAORAL X-RAY SYSTEM

    MDR report key: 1932128 · Received December 17, 2010

    Report

    Report Number
    3004115000-2010-00021
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Product Code
    EHD
    PMA / PMN Number
    K992610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ONSITE INSPECTION WAS CONDUCTED BASED ON THIS INCIDENT. IT WAS DETERMINED THAT A SHORTER LAG SCREW WAS UTILIZED IN PLACE OF THE PROVIDED 90MM LAG SCREW FOR SECURING THE X-RAY UNIT TO A 2 X 4 WOOD CONSTRUCTED WALL. THE 2.5 INCH LAG SCREWS THAT WERE USED DID NOT PROVIDE SUFFICIENT RETENTION FORCE OF THE MACHINE RESULTING IN THE TOP LAG SCREW PULLING FROM THE WALL WHILE THE ARM WAS FULLY EXTENDED. LABELING PROVIDED WITH THIS PRODUCT DESCRIBE THE MANUFACTURER'S PROPER INSTALLATION PRACTICES. AS A RESULT OF THE IMPROPER INSTALLATION BY THE SERVICE TECHNICIAN, THE PATIENT EXPERIENCED A SLIGHT CUT WITH BLEEDING INSIDE THE PATIENT'S MOUTH. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT CLAIMED TO BE FINE.

    Description of Event or Problem · 1

    THE INTRAORAL X-RAY UNIT FELL OFF THE WALL DURING USE AND HIT THE PATIENT IN THE FACE AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDEX EXPERT DC INTRAORAL X-RAY SYSTEM DENTAL X-RAY EQUIPMENT EHD GENDEX DENTAL SYSTEMS 110-0205G1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1