BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBRATE

    MDR report key: 19563767 · Received June 18, 2024

    Report

    Report Number
    2027467-2024-00063
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 18, 2024
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    MAX
    UDI-DI
    00190376522685
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLAINT REMAINS IN SITU. IT IS UNKNOWN WHETHER THE PATIENT IS EXPERIENCING ANY SYMPTOMS DUE TO THE EVENT OR IS HAVING REVISION SURGERY. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF DEVICE HISTORY RECORDS CANNOT BE PERFORMED. A RADIOGRAPH IMAGE CONFIRMED THE EVENT. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION AND/OR THE IMPLANT IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. LABELING REVIEW: WARNINGS/CAUTIONS/PRECAUTIONS: RISK FACTORS THAT MAY AFFECT SUCCESSFUL SURGICAL OUTCOMES INCLUDE: ALCOHOL ABUSE, OBESITY, PATIENTS WITH POOR BONE, MUSCLE AND/OR NERVE QUALITY. PATIENTS WHO USE TOBACCO OR NICOTINE PRODUCTS SHOULD BE ADVISED OF THE CONSEQUENCES THAT AN INCREASED INCIDENCE OF NON-UNION HAS BEEN REPORTED WITH PATIENTS WHO USE TOBACCO OR NICOTINE PRODUCTS. A CALIBRATE LTX IMPLANT MUST NOT BE RE-EXPANDED AND REUSED IF IT HAS BEEN FILLED WITH GRAFT, AS MECHANICAL FAILURE MAY OCCUR. POSSIBLE ADVERSE EFFECTS: INITIAL OR DELAYED LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS. POSTOPERATIVE MANAGEMENT: THE SURGEON SHOULD INSTRUCT THE PATIENT REGARDING THE AMOUNT AND TIME FRAME AFTER SURGERY OF ANY WEIGHT BEARING ACTIVITY. THE INCREASED RISK OF BENDING, DISLOCATION, AND/OR BREAKAGE OF THE IMPLANTED DEVICES, AS WELL AS AN UNDESIRED SURGICAL RESULT ARE CONSEQUENCES OF ANY TYPE OF EARLY OR EXCESSIVE WEIGHT BEARING, VIBRATORY MOTION, FALLS, JOLTS OR OTHER MOVEMENTS PREVENTING PROPER HEALING AND/OR FUSION DEVELOPMENT. IMPLANTED DEVICES SHOULD BE REVISED OR REMOVED IF BENT, DISLOCATED, OR BROKEN.

    Description of Event or Problem · 0

    AT THE 6 MONTHS POSTOPERATIVE VISIT, RADIOGRAPH IMAGES REVEALED A COLLAPSED EXPANDABLE CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626303 CALIBRATE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE, INC. 261-06185015 00190376522685

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female