BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTRACTION, INTERNAL

    MDR report key: 6204637 · Received December 27, 2016

    Report

    Report Number
    6204637
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 23, 2016
    Manufacturer
    KLS-MARTIN L.P.
    Product Code
    MQN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    A KLS MARTIN BONE BORN PALATAL EXPANDER WAS PLACED A WEEK PRIOR. DEVICE DISTRACTING AS PLANNED. AT COMPLETION OF DISTRACTION, THE CARE PROVIDER NOTICED THAT DISTRACTOR ARM WAS SLIGHTLY BENT. THE DEVICE WAS IN PLACE, NOT BROKEN AND MAINTAINING PALATAL WIDTH FOLLOWING DISTRACTION.

    Description of Event or Problem · 1

    A KLS MARTIN BONE BORN PALATAL EXPANDER WAS PLACED A WEEK PRIOR. DEVICE DISTRACTING AS PLANNED. AT COMPLETION OF DISTRACTION, THE CARE PROVIDER NOTICED THAT DISTRACTOR ARM WAS SLIGHTLY BENT. THE DEVICE WAS IN PLACE, NOT BROKEN AND MAINTAINING PALATAL WIDTH FOLLOWING DISTRACTION.

    Description of Event or Problem · 1

    A KLS MARTIN BONE BORN PALATAL EXPANDER WAS PLACED A WEEK PRIOR. DEVICE DISTRACTING AS PLANNED. AT COMPLETION OF DISTRACTION, THE CARE PROVIDER NOTICED THAT DISTRACTOR ARM WAS SLIGHTLY BENT. THE DEVICE WAS IN PLACE, NOT BROKEN AND MAINTAINING PALATAL WIDTH FOLLOWING DISTRACTION.

    Description of Event or Problem · 1

    A KLS MARTIN BONE BORN PALATAL EXPANDER WAS PLACED A WEEK PRIOR. DEVICE DISTRACTING AS PLANNED. AT COMPLETION OF DISTRACTION, THE CARE PROVIDER NOTICED THAT DISTRACTOR ARM WAS SLIGHTLY BENT. THE DEVICE WAS IN PLACE, NOT BROKEN AND MAINTAINING PALATAL WIDTH FOLLOWING DISTRACTION.

    Description of Event or Problem · 1

    A KLS MARTIN BONE BORN PALATAL EXPANDER WAS PLACED A WEEK PRIOR. DEVICE DISTRACTING AS PLANNED. AT COMPLETION OF DISTRACTION, THE CARE PROVIDER NOTICED THAT DISTRACTOR ARM WAS SLIGHTLY BENT. THE DEVICE WAS IN PLACE, NOT BROKEN AND MAINTAINING PALATAL WIDTH FOLLOWING DISTRACTION.

    Description of Event or Problem · 1

    A KLS MARTIN BONE BORN PALATAL EXPANDER WAS PLACED A WEEK PRIOR. DEVICE DISTRACTING AS PLANNED. AT COMPLETION OF DISTRACTION, THE CARE PROVIDER NOTICED THAT DISTRACTOR ARM WAS SLIGHTLY BENT. THE DEVICE WAS IN PLACE, NOT BROKEN AND MAINTAINING PALATAL WIDTH FOLLOWING DISTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857484 DISTRACTION, INTERNAL EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR MQN KLS-MARTIN L.P. 51-565-09-09

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other ORAL MAXILLOFACIAL SURGERY PATIENT SEEN IN THE CLI