BEUDAMED
    FDA Adverse Event Other Summary report: N

    TITANIUM MULTI-VECTOR DISTRACTOR PIN-HOLDING CLAMP/BODY

    MDR report key: 529741 · Received May 17, 2004

    Report

    Report Number
    529741
    Event Type
    Other
    Date Received
    May 17, 2004
    Date of Event
    May 12, 2004
    Report Date
    May 13, 2004
    Manufacturer
    SYNTHES USA. INC.
    Product Code
    MQN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REPOSITION THE MANDIBULAR DISTRACTOR ONE OF THE COMPONENTS (THE MULTI-DISTRACTOR PIN-HOLDING CLAMP/BODY) BROKE. IN ORDER TO ACCOMPLISH THE REPOSITIONING IT WAS NECESSARY TO REPLACE THE DEVICE WITH ANOTHER ONE. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM MULTI-VECTOR DISTRACTOR PIN-HOLDING CLAMP/BODY MAXILLO-FACIAL SURGICAL EQUIPMENT MQN SYNTHES USA. INC. * *
    2 TITANIUM MLTI-VECTOR DISTRACTOR PIN-HOLDING CLAMP/BODY MAXILLO-FACIAL SURGICAL EQUIPMENT MQN SYNTHES USA. INC. * *
    3 TITANIUM MULTI-VECTOR DISTRACTOR PIN-HOLDING CLAMP/BODY MAXILLO-FACIAL SURGICAL EQUIPMENT MQN SYNTHES USA. INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4.5 YR Other