BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-01861

    MDR report key: 3041867 · Received April 8, 2013

    Report

    Report Number
    2520274-2013-01861
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT REPORTED AS APPROXIMATELY (B)(6) 2013.

    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS PUT IN PLACE BY HEALTH PROFESSIONAL, BUT WAS OPERATED BY PATIENT'S FAMILY MEMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH TWO CMF DISTRACTORS TO TREAT BI-CORONAL LAMBDOID SYNOSTOSIS AND APERT SYNDROME HAS BEEN HAVING ISSUES WITH THE DISTRACTORS. THE LEFT FLEXIBLE ARM OF THE DISTRACTOR BODY CAME OFF. IT WAS ALSO REPORTED THAT THE RIGHT DISTRACTOR BODY IS JUST SPINNING AND NOT DISTRACTING. SURGEON MADE THE DECISION TO USE THESE DEVICES FOR AN OFF-LABEL PROCEDURE, WHICH IS NOT RECOMMENDED BY SYNTHES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR THE UNKNOWN DISTRACTOR THAT FELL APART. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    SURGEON REPORTS DISTRACTORS WILL BE REMOVED ON A DATE NOT YET DETERMINED. DURING DISTRACTION ONE FLEXIBLE ARM FELL OFF AND THE OTHER TURNED FREELY CAUSING ASYMMETRICAL DO. BY DOING CATCH UP TURNS THEY WERE ABLE TO COMPLETE DO SUCCESSFULLY WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142902 MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO