BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTERA SPINAL FIXATION SYSTEM

    MDR report key: 20206255 · Received September 12, 2024

    Report

    Report Number
    3005031160-2024-00030
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 12, 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
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCREWS MARKED DNI WERE INADVERTENTLY DISTRIBUTED BY A CONTRACT MANUFACTURER RESPONSIBLE FOR LABELING, STORAGE AND DISTRIBUTION OF CERTAIN XTANT MEDICAL PRODUCTS.THE AFFECTED SCREWS ARE DIRECT MARKED WITH DNI AS THE LOT NUMBER AND MAY NOT HAVE BEEN MANUFACTURED IN ACCORDANCE WITH RELEASED MANUFACTURING SPECIFICATIONS. THE AFFECTED SCREWS WERE MANUFACTURED IN A MANNER TO BE REPRESENTATIVE OF CLINICAL PRODUCTION PARTS REGARDING FORM AND FIT, BUT NOT NECESSARILY FUNCTION. THE AFFECTED SCREWS WERE MANUFACTURED FROM ANODIZED TITANIUM METAL WITH THE SAME OR SIMILAR SIZE AND DIMENSION. IF THE SURGEON OR HIS/HER ASSISTANTS DO NOT LOOK AT THE DIRECT MARKED LOT NUMBER OR DO NOT NOTICE THE DIFFERENCE IN ANODIZATION COLOR, HE/SHE MAY ATTEMPT TO IMPLANT THE AFFECTED SCREWS, WHICH CONTRIBUTE TO PRODUCT RISK. IF THE SURGEON ATTEMPTED TO IMPLANT THE AFFECTED SCREW(S) INTO A PATIENT, THE SCREW(S) MAY NOT PERFORM AS INTENDED (MAY BE DIFFICULT TO START THE SET SCREW, OR IT MAY NOT BE ABLE TO ENGAGE), WHICH THE SURGEON WOULD NOTICE DURING IMPLANTATION. TO-DATE THERE HAVE BEEN TWO (2) COMPLAINTS RECEIVED INVOLVING THE AFFECTED CORTERA SPINAL FIXATION SYSTEM SCREWS. THESE COMPLAINTS LED TO THE INVESTIGATION AND DISCOVERY OF THE DEFICIENCY IN THE DEVICES. XTANT MEDICAL HOLDINGS, INC. INITIATED A MEDICAL DEVICE RECALL ON 08/20/2024. XTANT IS CONDUCTING THIS RECALL WITH THE KNOWLEDGE OF THE FOOD AND DRUG ADMINISTRATION'S KNOWLEDGE (3005031160-09/04/2024-001-R).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEDICLE SCREW WITH DNI IMPRINTED ON THE SCREW TULIP WAS IMPLANTED. THE SCREW DID NOT LOCK DOWN AND WAS REMOVED AND REPLACED WITH A CLINICAL CORTERA SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585001 CORTERA SPINAL FIXATION SYSTEM SCREW NKB XTANT MEDICAL HOLDINGS, INC. 150150-65040 DNI 00810076563190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 150100-65045 - SCREW, POLY, SOLID, 6.5X45.