BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS-ALIF

    MDR report key: 16400618 · Received February 17, 2023

    Report

    Report Number
    3009962553-2022-00003
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    November 1, 2022
    Report Date
    February 17, 2022
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    UDI-DI
    0370078062651
    PMA / PMN Number
    K172083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO US THAT DURING IDYS-ALIF TIVAC SURGERY, UPON IMPACTION OF THE CAGE AND PLATE INTO THE DISC SPACE, TWO LOCKING RINGS SEPARATED FROM THE PLATE. THE TWO RINGS WERE RETRIEVED BY THE SURGEON. AS A CONSEQUENCE, 2 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WILL BE IMPLANTED. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO US THAT DURING IDYS-ALIF TIVAC SURGERY, UPON IMPACTION OF THE CAGE AND PLATE INTO THE DISC SPACE, TWO LOCKING RINGS SEPARATED FROM THE PLATE. THE TWO RINGS WERE RETRIEVED BY THE SURGEON. AS A CONSEQUENCE, 2 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WILL BE IMPLANTED. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

    Description of Event or Problem · 0

    THE PLATE WAS ATTACHED TO THE ALIF CAGE AND PLACED ON THE INSERTER. UPON IMPACTION OF THE CAGE INTO THE DISC SPACE BOTH OF THE BOTTOM LOCKING RINGS ON THE PLATE BECAME LOOSE AND DISENGAGED FROM THE PLATE. THIS HAPPENED DURING THE PLACEMENT OF THE CAGE AND BEFORE THE SCREWS WERE INTRODUCED. ACCORDING TO THE SURGEON AND THE REPRESENTATIVE PRESENT DURING THE CASE, THERE WAS NOTHING OUT OF THE ORDINARY THAT TOOK PLACE AND NO EXCESSIVE FORCE WAS USED. THE SURGEON REMOVED THE LOOSE RINGS WITH PICK-UPS AND SECURED THE CAGE TO THE L5 VERTEBRAL BODY USING TWO SCREWS WITHOUT SECURING THE PLATE TO S1. THE TWO DISENGAGED RINGS WERE DISPOSED OF INTO THE SHARPS CONTAINER BEFORE THE REPRESENTATIVE COULD SECURE THEM TO BE SENT BACK FOR EVALUATION. NO INJURY TO THE PATIENT OR SIGNIFICANT DELAYS WERE REPORTED.

    Description of Event or Problem · 0

    THE PLATE WAS ATTACHED TO THE ALIF CAGE AND PLACED ON THE INSERTER. UPON IMPACTION OF THE CAGE INTO THE DISC SPACE BOTH OF THE BOTTOM LOCKING RINGS ON THE PLATE BECAME LOOSE AND DISENGAGED FROM THE PLATE. THIS HAPPENED DURING THE PLACEMENT OF THE CAGE AND BEFORE THE SCREWS WERE INTRODUCED. ACCORDING TO THE SURGEON AND THE REPRESENTATIVE PRESENT DURING THE CASE, THERE WAS NOTHING OUT OF THE ORDINARY THAT TOOK PLACE AND NO EXCESSIVE FORCE WAS USED. THE SURGEON REMOVED THE LOOSE RINGS WITH PICK-UPS AND SECURED THE CAGE TO THE L5 VERTEBRAL BODY USING TWO SCREWS WITHOUT SECURING THE PLATE TO S1. THE TWO DISENGAGED RINGS WERE DISPOSED OF INTO THE SHARPS CONTAINER BEFORE THE REPRESENTATIVE COULD SECURE THEM TO BE SENT BACK FOR EVALUATION. NO INJURY TO THE PATIENT OR SIGNIFICANT DELAYS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656655 IDYS-ALIF IDYS-ALIF PLATE H14MM OVD CLARIANCE SAS (01)03700780627127(17)270201(10)I750C-IA08Y I750C-IA08Y 0370078062651

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown