BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITI CERVICAL STANDALONE INTERBODY SYSTEM

    MDR report key: 21001827 · Received December 23, 2024

    Report

    Report Number
    2027467-2024-00169
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 23, 2024
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    OVE
    PMA / PMN Number
    K202812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCREW HAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE IDENTIFYING PART AND LOT NUMBER WERE NOT PROVIDED. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW BROKE WHILE BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85020 IDENTITI CERVICAL STANDALONE INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE ALPHATEC SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown