BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANAMA ANTERIOR CERVICAL PLATE SINGLE LEVEL 12MM

    MDR report key: 14014995 · Received April 4, 2022

    Report

    Report Number
    MW5108760
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 1, 2022
    Manufacturer
    FLOSPINE LLC
    Product Code
    KWQ
    UDI-DI
    B1830810000120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A FALL ONE WEEK POST OP, DID NOT FEEL ANY DISCOMFORT IN NECK BUT DID RECEIVE ABRASION ON HEAD. PATIENT CONSULTED WITH SURGEON. SCREW HEAD BACKED OUT 10% AND LOCKING MECHANISM DISLODGED. CERVICAL PLATE WAS REMOVED AND REPLACEMENT CERVICAL PLATE WAS INSERTED ON (B)(6) 2022. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440305 PANAMA ANTERIOR CERVICAL PLATE SINGLE LEVEL 12MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ FLOSPINE LLC 08-1000-012 B1830810000120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention