BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF SCREW MAXDRIVE DRILL FREE

    MDR report key: 6147420 · Received December 6, 2016

    Report

    Report Number
    9610905-2016-00045
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 15, 2016
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    HRS
    UDI-DI
    00888118047793
    PMA / PMN Number
    K971297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED USING VISUAL AND STEREO MICROSCOPIC INSPECTION OF THE SCREW HEAD THAT WAS RETURNED. TENSILE CRACKS WERE OBSERVED UNDER THE STEREO MICROSCOPE. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED SINCE NO LOT NUMBER WAS PROVIDED. THE RESULTS OF THE INVESTIGATION CONCLUDE THAT THE ROOT CAUSE FOR BREAKAGES WERE DUE TO MECHANICAL OVERLOAD ON THE DEVICE. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SURGEON WAS PLATING A LEFT ANGLE FRACTURE. THE SURGEON PRE-DRILLED A PILOT HOLE USING A RIGHT ANGLE DRILL, AND THEN PROCEEDED TO SCREW THE IMPLANT WITH THE DRILL FREE SCREW. THE SCREW HEAD BROKE OFF WHILE BEING IMPLANTED INTO THE PATIENTS MANDIBLE. NO CONSEQUENCES TO THE PATIENT DUE TO THE SCREW BREAKING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799270 LEVEL ONE CMF SCREW MAXDRIVE DRILL FREE DRILL FREE SCREW HRS KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 25-879-07-91 00888118047793

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other