BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNATORQUE ATTACHMENT

    MDR report key: 3429614 · Received October 15, 2013

    Report

    Report Number
    2916440-2013-00002
    Event Type
    Other
    Date Received
    October 15, 2013
    Date of Event
    September 27, 2013
    Report Date
    October 15, 2013
    Manufacturer
    PRO-DEX MICRO MOTORS INC.
    Product Code
    EFB
    PMA / PMN Number
    K896876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USER DID NOT IDENTIFY PRODUCT DAMAGE PRIOR TO USE. DAMAGE PRODUCT LATCH LEVER ALLOWED LEVER RETURN SPRING TO DISLODGE. LATCH LEVER RELEASED TOOL DUE TO DISLODGED RETURN SPRING TO DISLODGE RETURN SPRING AND USER OPERATION. CONCLUSION: HANDLING OF PRODUCT DAMAGED LATCH LEVER ALLOWING RETURN SPRING TO DISLODGE.

    Description of Event or Problem · 1

    DR SAID HE THOUGHT HE LOCKED THE BURR, BUT IT FELL OUT IN THE PT MOUTH, PT WAS ABLE TO COUGH IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527411 DYNATORQUE ATTACHMENT LOW-SPEED LATCH HEAD EFB PRO-DEX MICRO MOTORS INC. 24017-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK