BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEX PEDICLE SCREW SYSTEM

    MDR report key: 14639066 · Received June 8, 2022

    Report

    Report Number
    3005031160-2022-00021
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 3, 2022
    Report Date
    June 8, 2022
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    MNI
    UDI-DI
    M697X07000401
    PMA / PMN Number
    K152132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED SYSTEM SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THE DISTAL TIP OF THE DRIVER WAS FRACTURED AND THERE WERE ROTATIONAL WEAR MARKS AROUND THE REMAINING PORTION OF THE TIP. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE RETURNED SCREWDRIVER COMPLAINT LOT AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 2/18/2019. THE COMPLAINT SCREWDRIVER IS INTENDED TO BE USED WITH TORQUE-LIMITING HANDLES FROM THE MANUFACTURER TO APPROPRIATELY LIMIT APPLIED TORQUE. IT IS UNKNOWN WHAT REQUIRED TORQUE IS APPROPRIATE FOR PLACING AND REMOVING THE ALTERNATE MANUFACTURER'S SYSTEM SCREWS. THE ROOT CAUSE OF THIS COMPLAINT IS EXCESSIVE ROTATIONAL FORCE APPLIED TO THE SCREWDRIVER TO REMOVE A SYSTEM SCREW FROM AN ALTERNATE MANUFACTURER. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM INSTRUMENT MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE ATTEMPTING TO REMOVE A SYSTEM SCREW FROM AN ALTERNATE MANUFACTURER. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 6/03/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894555 FORTEX PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI XTANT MEDICAL HOLDINGS, INC. X070-0040 059814 M697X07000401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other