BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MOTOR SYSTEM 115V

    MDR report key: 7116337 · Received December 14, 2017

    Report

    Report Number
    9681479-2017-00006
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 29, 2017
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EBW
    PMA / PMN Number
    K060287
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER W&H AND WILL BE ANALYSED AND A FOLLOW-UP REPORT WILL SENT TO FDA AFTERWARDS.

    Description of Event or Problem · 1

    IT WAS REPORTET THAT THE (B)(4) MOTOR STOPPED WORKING AND WAS OVER HEATING DURING A PROCEDURE. THE PATIENT'S SURGICAL SITE WAS CLOSED UP AND THE PATIENT LEFT WITHOUT AN IMPLANT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899336 ZIMMER MOTOR SYSTEM 115V MOTOR SYSTEM EBW W&H DENTALWERK BUERMOOS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention