BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO ZURICH DISTRACTOR

    MDR report key: 5079344 · Received September 15, 2015

    Report

    Report Number
    9610905-2015-00040
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    July 22, 2015
    Report Date
    September 15, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    MQN
    PMA / PMN Number
    K010139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS SENT BACK FOR EVALUATION. IT IS DETERMINED THAT THE COMPLAINT PERCENTAGE FALLS WELL WITHIN THE PRODUCT RISK LIMITS THAT ARE ADHERED TO AT KLM. IN ADDITION TO NO DEVICE BEING RETURNED, PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE NO LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION WAS PROVIDED. DUE TO NO DEVICE BEING RETURNED AND NO LOT NUMBER PROVIDED, THE ROOT CAUSE FOR THE BREAKAGE CANNOT BE DETERMINED. IF FURTHER INFORMATION CAN BE GATHERED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATED REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THREE WEEKS FOLLOWING IMPLANTATION, THE DISTRACTOR FOOTPLATE BROKE OFF THE DISTRACTOR BODY. AS A RESULT OF THE BREAKAGE, A SECONDARY SURGERY WAS PERFORMED TO REMOVE THE BROKEN DISTRACTOR AND A REPLACEMENT DISTRACTOR WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610432 MICRO ZURICH DISTRACTOR BONE PLATE MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 51-440-30-09 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other