BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIP LP

    MDR report key: 16840363 · Received April 28, 2023

    Report

    Report Number
    3010326971-2023-00002
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    October 26, 2022
    Report Date
    April 25, 2023
    Manufacturer
    AURORA SPINE, INC.
    Product Code
    PEK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A SPINAL IMPLANT DISLODGED IN A PATIENT. DR. COCCARO PERFORMED A REVISION OF THE SPINAL IMPLANT SURGERY WHICH WAS REQUIRED FOR EXPLANTATION OF THE MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737754 ZIP LP ZIP LP, 16MM X 45MM PEK AURORA SPINE, INC. 103-016-045 5969-1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization