BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIAL DISTRACTOR

    MDR report key: 5108267 · Received September 28, 2015

    Report

    Report Number
    9610905-2015-00044
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 23, 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

    THE DEVICES WERE OPTICALLY ASSESSED AND STEREOSCOPICALLY INVESTIGATED IN THE LAB. THE STEREO MICROSCOPIC INVESTIGATION REVEALED A TENSILE CRACK DUE TO STRESS. 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 STRESSES PLACED UPON THE DEVICE. 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

    IT WAS REPORTED THAT THE PATIENT FELL, CAUSING THE TWO DISTRACTORS TO BREAK. THE DISTRACTION CONSOLIDATION PERIOD WAS NOT COMPLETE; THEREFORE, A SECONDARY SURGERY WAS PERFORMED ON (B)(6) 2015 TO REMOVE THE BROKEN DISTRACTORS AND REPLACE THEM WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639189 CRANIAL DISTRACTOR BONE PLATE MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 51-563-30-09 32876362, 32993799

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Other