BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPIAN SPINAL SYSTEM

    MDR report key: 6878928 · Received September 20, 2017

    Report

    Report Number
    3004774118-2017-00128
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 15, 2017
    Report Date
    August 21, 2017
    Manufacturer
    K2M INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. INVESTIGATION BASED ON PROVIDED INFORMATION SUGGEST THAT THE CORRECT HANDLE WAS NOT PRESENT IN THE SET. THE EVENT REPORT INDICATES THE REPRESENTATIVE CONTACTED K2M IMMEDIATELY AND WAS DIRECTED IN PROPER HANDLE SELECTION. THE SET WAS SUPPLIED FROM ANOTHER SITE SO CAUSE OF THE HANDLE CHANGE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M INC. THAT A SURGERY WAS PERFORMED IN WHICH THE TORQUE HANDLE USED WAS INCORRECT. SINCE THE WRONG TORQUE HANDLE WAS USED THE SCREWS WERE NOT TORQUED OFF AND LEFT IN THE PLATE IN THE PATIENTS'S BODY. SURGERY TOOK PLACE ON (B)(6) 2017.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M INC. THAT A SURGERY WAS PERFORMED IN WHICH THE TORQUE HANDLE USED WAS INCORRECT. SURGERY TOOK PLACE ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660267 CASPIAN SPINAL SYSTEM SPINAL FIXATION SYSTEM LXH K2M INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1