BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-ALIF

    MDR report key: 15138677 · Received August 1, 2022

    Report

    Report Number
    3009962553-2022-00002
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    June 24, 2022
    Report Date
    July 28, 2022
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    UDI-DI
    03700780627127
    PMA / PMN Number
    K172083
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE INSERTING A SCREW THROUGH THE PLATE, ONE OF THE PLATE'S LOCKING SLEEVES REMAINED SLIGHTLY PROUD OF THE PLATE, PREVENTING THE SCREW FROM SITTING FLUSH IN THE PLATE. 3 SCREWS WERE USED NORMALLY WITHOUT PROBLEM. THE FOURTH SCREW COULD NOT BE IMPLANTED CORRECTLY INTO THE PLATE PREVENTING THE SCREW FROM SITTING FLUSH IN THE PLATE. EVEN IF THIS SCREW WAS LEFT IN PLACE IN A SAFE PLACE, THE CLOSING MECHANISM DID NOT WORK PROPERLY. ACCORDINGLY, THIS EVENT IS REPORTABLE AS A MALFUNCTION.

    Additional Manufacturer Narrative · 0

    WHILE INSERTING A SCREW THROUGH THE PLATE, ONE OF THE PLATE'S LOCKING SLEEVES REMAINED SLIGHTLY PROUD OF THE PLATE, PREVENTING THE SCREW FROM SITTING FLUSH IN THE PLATE. 3 SCREWS WERE USED NORMALLY WITHOUT PROBLEM. THE FOURTH SCREW COULD NOT BE IMPLANTED CORRECTLY INTO THE PLATE PREVENTING THE SCREW FROM SITTING FLUSH IN THE PLATE. EVEN IF THIS SCREW WAS LEFT IN PLACE IN A SAFE PLACE, THE CLOSING MECHANISM DID NOT WORK PROPERLY. ACCORDINGLY, THIS EVENT IS REPORTABLE AS A MALFUNCTION. ON 10/28/2022: RESPONSE FROM MANUFACTURER CLARIANCE SAS: "AS YOU KNOW THE R&D DEPARTMENT ASKED FOR THE X-RAYS OF THE PATIENT TO BE ABLE TO ANALYZE THE INCIDENT. KNOWING THAT WE DIDN'T GET THE X-RAYS, THAT YOU TRIED TO GET BUT NO ANSWER, WE ARE SORRY TO SAY THAT WE CAN'T PERFORM THE ANALYSIS OF THIS CASE."

    Description of Event or Problem · 0

    WHILE INSERTING A SCREW THROUGH THE PLATE, ONE OF THE PLATE'S LOCKING SLEEVES REMAINED SLIGHTLY PROUD OF THE PLATE, PREVENTING THE SCREW FROM SITTING FLUSH IN THE PLATE. THE SCREW WAS LEFT IN PLACE.

    Description of Event or Problem · 0

    WHILE INSERTING A SCREW THROUGH THE PLATE, ONE OF THE PLATE'S LOCKING SLEEVES REMAINED SLIGHTLY PROUD OF THE PLATE, PREVENTING THE SCREW FROM SITTING FLUSH IN THE PLATE. THE SCREW WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286804 IDYS-ALIF IDYS-ALIF PLATE H14MM OVD CLARIANCE SAS (01)03700780627127(17)260701(10)M667X-M613Y M667X-M613Y 03700780627127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown