BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTERA SPINAL FIXATION SYSTEM

    MDR report key: 20246892 · Received September 18, 2024

    Report

    Report Number
    3005031160-2024-00032
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 18, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    NKB
    UDI-DI
    00810076563190
    PMA / PMN Number
    K221403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED SCREW SHOWED MINIMAL SURFACE SCRATCHES. THE TULIP APPEARS TO HAVE BEEN SWAGED PROPERLY AND IT DOES NOT ROTATE WHICH SUGGESTS THAT THE TULIP IS IN THE CORRECT POSITION. TESTING WITH A GAGE SHOWED THAT THE GAGE WOULD NOT THREAD ONTO THE SCREW. FURTHER INVESTIGATION SHOWED THE SCREW THREADING WAS DAMAGED. A DHR REVIEW WAS PERFORMED FOR THE IMPLANT LOT WHICH MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. DUE TO THE VENDOR INSPECTION REQUIREMENTS AND THE ABILITY TO ATTACH THE SCREWDRIVER, IT IS LIKELY THAT THE DAMAGED SCREW THREADING WAS CAUSED BY UNINTENDED USER ERROR OR FORCE. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 06/28/2024, RESULTING IN AN APPROXIMATE FIELD LIFE OF THREE MONTHS. BASED ON THE INFORMATION REVIEWED, THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE UNINTENDED USER ERROR. THERE HAVE BEEN ZERO OTHER COMPLAINTS OF SIMILAR NATURE FOR THIS IMPLANT IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR COMPLAINTS OF SIMILAR SCREW DEFICIENCIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FIXATION SURGERY INVOLVING THE PEDICLE SCREW SYSTEM. DURING THE SURGERY IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY WITH SITTING THE ROD INTO THE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236509 CORTERA SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB XTANT MEDICAL HOLDINGS, INC 150100-65045 AP24000082 00810076563190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown