BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR

    MDR report key: 3101801 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02468
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K080153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    AN INFANT WITH MANDIBULAR DEFICIENCY WAS TREATED WITH BI-LATERAL BC DISTRACTORS ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE THREADS OF THE EXTENSION ARMS DO NOT ENGAGE THE DISTRACTOR BODIES IMMEDIATELY OR SECURELY. THE DISTRACTOR BEGINS TO DISTRACT THEN JUST SPINS FREELY. EVENTUALLY THE THREADS ENGAGE THE DISTRACTOR, BUT NOT CONSISTENTLY. WHEN THIS HAPPENS, THE DISTRACTOR IS MOVING FORWARD. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204114 REMOVABLE EXTENSION ARM-FLEX 30MM FOR CMF DISTRACTOR MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 DA