BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXDRIVE MINI SCREW

    MDR report key: 5173587 · Received October 24, 2015

    Report

    Report Number
    9610905-2015-00052
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 13, 2015
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO.
    Product Code
    JEY
    PMA / PMN Number
    K943347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREWS WERE OPTICALLY ASSESSED AND STEREO MICROSCOPICALLY INVESTIGATED IN THE LAB. THE STEREO MICROSCOPIC INVESTIGATION REVEALED A TENSILE CRACK DUE TO MECHANICAL OVERLOAD. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS DISCOVERED. PRODUCT DEVICE HISTORY RECORDS WERE ALSO REVIEWED BASED ON THE LOT NUMBER PROVIDED AND REVEALED NO ABNORMALITIES. THE RESULTS OF THE INVESTIGATION CONCLUDE THAT THE ROOT CAUSE FOR BREAKAGE WAS DUE TO A MECHANICAL OVERLOAD ON THE SCREWS. IF FURTHER INFORMATION CAN BE GATHERED THAT CAN ADD VALUE TO THE CONTENTS OF THE INVESTIGATED REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING IMPLANTATION, THE SCREW HEADS BROKE AND SHEERED OFF. THE REMAINING PORTION OF THE SCREW SHAFTS WERE UNABLE TO BE EXPLANTED AND REMAIN IN THE PATIENT'S BONE. NO SECONDARY SURGERY IS SCHEDULED FOR SCREW REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703061 MAXDRIVE MINI SCREW BONE SCREW JEY KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. 25-872-09-09 32937855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other