BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERLA TL

    MDR report key: 20999803 · Received December 23, 2024

    Report

    Report Number
    20999803
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    April 29, 2024
    Report Date
    December 6, 2024
    Manufacturer
    SPINEART SA
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PEDICLE FINDER TIP BROKE OFF. ALL PIECES RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109963 PERLA TL APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SPINEART SA TLF-IN 01 50-N

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male