BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLA III-D SPINAL DEFORMITY SYSTEM

    MDR report key: 15933630 · Received December 7, 2022

    Report

    Report Number
    3004719693-2022-00002
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    October 8, 2022
    Report Date
    December 7, 2022
    Manufacturer
    INNOVASIS, INC.
    Product Code
    NKB
    UDI-DI
    M711E20020
    PMA / PMN Number
    K140238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT OCCURRED IN (B)(4), PERU WHEREIN A PATIENT HAD A SPINAL DEFORMITY CONSTRUCT OF MULTIPLE PEDICLE SCREWS IMPLANTED WITH RODS AND LOCKING CAPS. AT A TWO-WEEK POST-OPERATIVE FOLLOW-UP, THE PATIENT HAD NOTICEABLE DEFORMITY, PAIN AND FUNCTIONAL LIMITATION. IMAGING SHOWED MULTIPLE LOCKING CAPS CAME LOOSE, RELEASING THE RODS FROM THE CONSTRUCT IN THE LUMBOSACRAL AREA. REVISION SURGERY WAS PERFORMED TO REPLACE 8 OF THE ORIGINAL 18 SCREWS AND LOCKING CAPS, WHILE THE REMAINING SCREWS, LOCKING CAPS AND RODS REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044844 EXCELLA III-D SPINAL DEFORMITY SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB INNOVASIS, INC. E2002 2010 M711E20020

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Unknown Required Intervention| H