BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED ROD, 5.5 X 45

    MDR report key: 22646485 · Received July 29, 2025

    Report

    Report Number
    MW5173489
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    December 6, 2021
    Report Date
    July 28, 2025
    Manufacturer
    CAPTIVA SPINE, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO SUBMIT A REPORT ABOUT HER IMPLANTED DEVICES. SHE SAID ONE DAY SHE WAS WALKING, AND SHE EXPERIENCED SHOOTING PAIN, AND SHE WENT TO EMERGENCY ROOM. SHE SAID SHE WAS REFERRED TO (B)(6). SHE SAID THE ORTHOPEDIC DIAGNOSED HER WITH DEGENERATIVE DISC DISEASED, SPINAL STENOSIS, HERNIATED DISC. THE DOCTOR PRESCRIBED PAIN MEDICATION FOR HER PAIN. THE DOCTOR TOLD HER THAT SHE NEEDS A PROCEDURE CALLED POSTERIOR SPINAL FUSION WITH DECOMPRESSION. SHE SAID THE PAIN MEDICATION DID NOT ALLEVIATE HER PAIN. SHE WAS HAVING AN ONGOING PAIN. SHE SAID THE DOCTOR TOLD HER HE NO LONGER CARES FOR HER BECAUSE OF HER INSURANCE. PATIENT CODES: 1994, 2263, 4581. DEVICE CODE: 2993. REFERENCE REPORTS: #MW5173490, #MW5173491, #MW5173492, #MW5173493.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676373 CURVED ROD, 5.5 X 45 ORTHOSIS, SPINAL PEDICLE FIXATION MNI CAPTIVA SPINE, INC. 2455-2045

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female