BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRA-A

    MDR report key: 17316304 · Received July 13, 2023

    Report

    Report Number
    3010197239-2023-00001
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 12, 2023
    Manufacturer
    CAMBER SPINE TECHNOLOGIES
    Product Code
    MAX
    UDI-DI
    B030SPA263208150
    PMA / PMN Number
    K162986
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WENT UNDER A L5/S1 ALIF SURGERY ON (B)(6) 2023. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH A (B)(6) CAGE PACKED WITH INFILL CBM INTO THE PATIENT'S L5/S1 DISC SPACE, POST-DISCECTOMY. THE SURGEON UTILIZED ORTHOFIX'S UNITY ANTERIOR LUMBAR PLATING SYSTEM FOR SUPPLEMENTAL FIXATION, WHERE HE IMPLANTED AN ANTERIOR SACRAL PLATE SECURED WITH TWO DIVERGENT SCREWS INTO L5 AND TWO CONVERGENT SCREWS INTO S1. THERE WERE NO CONSPICUOUS INTRA-OPERATIVE COMPLICATIONS OTHER THAN A REDIRECTION OF INITIAL TRAJECTORY FOR ONE SACRAL SCREW. THE PATIENT LEFT THE FACILITY WITHIN 24 HOURS. TWO WEEKS POST-OP, THE PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN. X-RAY & CT IMAGING REVEALED NOTABLE BACK-OUT AND ANTERIOR MIGRATION OF ALL HARDWARE (PLATE/SCREW CONSTRUCT AND CAGE) AS WELL AS BONE FRACTURES INCLUDING AN L5 CORONAL FRACTURE THROUGH THE BODY'S ENTIRETY AND A TRANSVERSE S1 FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE SURGEON REMOVED ALL THE IMPLANTS (PLATES, SCREWS AND CAGE). THE EXPLANTED CAGE (B)(6) SHOWED NO VISIBLE SIGNS OF DAMAGE/DEFECT. THE SURGEON IMPLANTED ALPHAETEC'S IDENTI-TI STANDALONE ALIF CAGE AND SECURED IT USING THE ORTHROS MIS SCREWS AT L5 AND S1 PEDICLES TO PROVIDE ADDITIONAL STABILIZATION. THE RECOVERY OF THE PATIENT WAS QUICK WITH NO COMPLICATIONS POST REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312657 SPIRA-A SPIRA-A MAX CAMBER SPINE TECHNOLOGIES SPA-2632-0815 CA98917A2 B030SPA263208150

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention