BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BC DISTRACTOR BODY END ACT. 25MM FOR CMF DISTRACTOR

    MDR report key: 3101784 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02466
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQN
    PMA / PMN Number
    K060138
    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

    A REVIEW DEVICE HISTORY RECORDS FOR THE LOT REVEALED THAT THE PRODUCT CONFORMED TO ALL REQUIREMENTS. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    AN (B)(6) 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 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203710 BC DISTRACTOR BODY END ACT. 25MM FOR CMF DISTRACTOR MQN SYNTHES MONUMENT 6450702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 DA Required Intervention