BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER CERVICAL PLATING SYSTEM

    MDR report key: 10541049 · Received September 16, 2020

    Report

    Report Number
    3005031160-2020-00020
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 16, 2020
    Manufacturer
    XTANT MEDICAL
    Product Code
    HXX
    UDI-DI
    M697N600001601
    PMA / PMN Number
    K170224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY RECEIVED NOTIFICATION ON 8/20/2020 OF AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE A SYSTEM SCREW WAS ROTATED. THE FRACTURED PORTION OF THE COMPLAINT INSTRUMENT WAS REMOVED FROM THE SURGICAL SITE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT. A VISUAL ASSESSMENT OF THE RETURNED SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS, SURFACE SCRATCHES, AND WEAR TO THE TIN COATING. A SMALL PORTION OF THE DISTAL TIP OF THE DRIVER WAS FRACTURED AND NOT PRESENT. A FUNCTIONALITY ASSESSMENT COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED COMPLAINT INSTRUMENT. A DHR REVIEW WAS PERFORMED FOR THE RETURNED LOT, AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 7/18/2016. THE DISTAL TIP OF THE SCREWDRIVER COULD FRACTURE IF THERE WERE EXCESSIVE TORQUE APPLIED TO THE INSTRUMENT OR IF A LATERAL FORCE WAS APPLIED TO THE SCREWDRIVER WHILE SEATED IN A SYSTEM SCREW. IF EXCESSIVE TORQUE WAS APPLIED TO THE SCREWDRIVER, IT MAY CONTRIBUTE TO THE DISTAL TIP FRACTURING FROM THE BODY OF THE INSTRUMENT. IF A SCREWDRIVER HAD LATERAL FORCE APPLIED WHILE SEATED IN A SYSTEM SCREW, IT MAY CONCENTRATE FORCES TO THE INTERFACE BETWEEN THE DRIVER AND SCREW RESULTING IN AN INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION ON 8/20/2020 OF AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE A SYSTEM SCREW WAS ROTATED. THE FRACTURED PORTION OF THE COMPLAINT INSTRUMENT WAS REMOVED FROM THE SURGICAL SITE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003896 SPIDER CERVICAL PLATING SYSTEM SCREWDRIVER ASSEMBLY HXX XTANT MEDICAL N60000160 739601 M697N600001601

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other