BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBMESH FOOTPL2 TYPE B F/CMF DISTRACT

    MDR report key: 2926021 · Received January 23, 2013

    Report

    Report Number
    2530088-2013-00059
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    August 19, 2012
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MQN
    PMA / PMN Number
    K060138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR PART NUMBER 04.315.402, 2.0MM MANDIBLE MESH FOOT, B TYPE FOR CMF DISTRACTOR, LOT NUMBER U101001 AND RAW MATERIAL LOT NUMBER 4830091 SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE A DISCONNECTION OF THE EXTRACTION ARM COULD NOT BE ACHIEVED. THE DISTRACTOR WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 2 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32602 MANDIBMESH FOOTPL2 TYPE B F/CMF DISTRACT MANDIBMESH FOOT MQN SYNTHES BRANDYWINE U101001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DISTRACT-BODY, MESH FOOT, LOCKING SCREW