BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMOVABLE EXTENSION ARM-FLEX 40MM FOR CMF DISTRACTOR

    MDR report key: 9687050 · Received February 10, 2020

    Report

    Report Number
    2939274-2020-00731
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    August 8, 2019
    Report Date
    January 14, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MQN
    UDI-DI
    10887587015675
    PMA / PMN Number
    K170818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: PBJ. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE IMPLANT DISTRACTION DEVICE DID NOT REALLY WORK LIKE IT WAS SUPPOSED TO. THERE WAS SOME PATIENT ERROR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND THE OUTCOME ARE UNKNOWN. THIS IS REPORT 04 OF 04 OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153185 REMOVABLE EXTENSION ARM-FLEX 40MM FOR CMF DISTRACTOR MANDIBLE DISTRACTION DEVICES MQN WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.315.127 10887587015675

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO