BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 POLYAXIAL SCREW 6.0X35MM

    MDR report key: 4231817 · Received October 15, 2014

    Report

    Report Number
    3005673311-2014-00071
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    November 30, 2014
    Report Date
    September 2, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWP
    PMA / PMN Number
    K032219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE BREAKAGE SURFACE OF BOTH SCREWS SHOWED ARREST LINE, WHICH ARE INDICATIONS OF A FATIGUE FRACTURE DUE TO DYNAMIC BENDING FORCES. THE MOST LIKELY CAUSE OF THIS IS DELAYED OR MISSING BONE INFUSION, WHICH CAN RESULT IN BREAKAGE OF THE IMPLANT. THE MANUFACTURING DOCUMENTS WERE CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION AND VALID AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS FOR MATERIAL OR MANUFACTURING DEFECTS FOUND. NO OTHER SIMILAR INCIDENTS HAVE BEEN REPORTED CONCERNING THIS BATCH. THE BREAKAGE OF THE SCREWS IS MOST LIKELY RELATED TO PATIENT CONDITION. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SCREWS (2) BROKE AT THE MOMENT OF PATIENT FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652693 S4 POLYAXIAL SCREW 6.0X35MM BONE SCREW KWP AESCULAP AG & CO. KG SW773T 51820924

    Patients

    Seq Age Sex Outcome Treatment
    1