BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSDSIGN CRANIAL PSI

    MDR report key: 17848184 · Received September 29, 2023

    Report

    Report Number
    3013282271-2023-00008
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 21, 2023
    Manufacturer
    OSSDSIGN
    Product Code
    PJN
    PMA / PMN Number
    K212414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN EXAMINING THE STERILE PACKAGING OF THE DEVICE PRIOR TO OPENING AN OBJECT RESEMBLING A SHORT HAIR WAS DISCOVERED. THE OBJECT WAS POSITIONED INSIDE THE SAME BAG AS THE MEDICAL DEVICE BUT NOT IN DIRECT CONTACT WITH THE DEVICE. THE HOSPITAL STAFF PROCEEDED TO REMOVE THE FOREIGN BODY AND EXAMINE THE DEVICE FOR ANY OTHER FOREIGN OBJECTS. NO OTHER OBJECTS WERE FOUND AND THE SURGEONS DECIDED TO PROCEED WITH IMPLANTATION OF THE DEVICE. THE OUTCOME OF THE PROCEDURE WAS GOOD AND THERE HAS NOT BEEN ANY HARM REPORTED FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345521 OSSDSIGN CRANIAL PSI CRANIOPLASTY PLATE PJN OSSDSIGN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention