BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCI PRE-BENT PLATE

    MDR report key: 6191460 · Received December 20, 2016

    Report

    Report Number
    9610905-2016-00057
    Event Type
    Injury
    Date Received
    December 20, 2016
    Report Date
    November 25, 2016
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    MQN
    UDI-DI
    00888118095015
    PMA / PMN Number
    K032442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED USING VISUAL AND STEREO MICROSCOPIC INSPECTION ON THE PLATE THAT WAS RETURNED. PROCESS EVALUATION WAS ALSO COMPLETED ON THE LOT NUMBER PROVIDED. TENSILE CRACKS WERE OBSERVED UNDER THE STEREO MICROSCOPE. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS OBSERVED. THE PRODUCT HISTORY DEVICE RECORDS WERE ALSO REVIEWED BASED ON THE LOT NUMBER PROVIDED, AND NO ABNORMALITIES WERE FOUND. 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 WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECONSTRUCTION PLATE BROKE. PATIENT WAS COMPLIANT HOWEVER THE DOCTOR BELIEVES THE PATIENT MIGHT HAVE GRINDED OR CLINCHED DURING THE NIGHT CAUSING STRESS. PLATE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840137 PCI PRE-BENT PLATE PLATE MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 60-650-01-04 UNKNOWN 00888118095015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other