BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSDSIGN CRANIAL PSI

    MDR report key: 17515043 · Received August 11, 2023

    Report

    Report Number
    3013282271-2023-00007
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 10, 2023
    Manufacturer
    OSSDSIGN
    Product Code
    PJN
    PMA / PMN Number
    K212414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PREPARATION FOR SURGERY IT WAS DISCOVERED THAT THE DEVICE AVAILABLE WAS INCORRECT AND WOULD NOT FIT THE PATIENT. WHEN IT WAS DISCOVERED THE PROCEDURE HAD NOT YET BEEN INITIATED AND THE PATIENT HAD NOT BEEN ADMINISTERED ANESTHESIA. SURGERY WAS CAONCELLED AND POSTPONED TO LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181816 OSSDSIGN CRANIAL PSI CRANIOPLASTY PLATE PJN OSSDSIGN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization