BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINDEMANN BURR 1.5X14X70MM

    MDR report key: 6667698 · Received June 26, 2017

    Report

    Report Number
    2916714-2017-00013
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 26, 2017
    Manufacturer
    ORCHID UNIQUE ORTHOPEDIC SOLUTIONS
    Product Code
    GEY
    PMA / PMN Number
    K913262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING THE EEC OPERATION A BROKEN PART WAS LEFT IN THE ORAL CAVITY. THIS MISSING/BROKEN PART WAS FOUND BY USING A X-RAY AND REMOVED FROM THE PATIENT. THE SURGICAL DELAY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448134 LINDEMANN BURR 1.5X14X70MM HIGH SPEED POWER SYSTEMS GEY ORCHID UNIQUE ORTHOPEDIC SOLUTIONS MD754

    Patients

    Seq Age Sex Outcome Treatment
    1 Other