BEUDAMED
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    IDYS-TLIF TIVAC

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code OVD·January 9, 2024

    IDYS-TLIF TIVAC

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code OVD·January 17, 2024

    ERISMA-LP

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code NKB·August 30, 2018

    IDYS-ALIF

    FDA Adverse Event
    Injury ·CLARIANCE SAS·Product code OVD·November 14, 2024

    ERISMA-LP

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code NKB·August 30, 2018

    ERISMA LP

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS.·Product code HXX·August 31, 2016

    IDYS-TLIF TIVAC

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code OVD·December 14, 2023

    ERISMA-LP MIS

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code NKB·March 4, 2020

    IDYS-TLIF TIVAC

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code MAX·January 31, 2020

    ERISMA-LP

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·August 24, 2016

    ERISMA-LP

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·March 6, 2020

    ERISMA LP

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·March 4, 2020

    ERISMA-LP MIS

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·March 10, 2021

    ERISMA-LP MIS

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·September 26, 2019

    ERISMA-LP MIS

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·December 30, 2019

    ERISMA-LP MIS

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·October 1, 2019

    ERISMA LP

    FDA Adverse Event
    Malfunction ·CLARIANCE SAS·Product code HXX·October 4, 2019

    Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The EleganceAnterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Eleganceplates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance Anterior Cervical plate. Detailed information concerning the surgical technique of the EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

    FDA Recall
    Open, Classified ·Clariance-SAS 18 Rue Robespierre Beaurains France·Product code KWQ·February 20, 2026

    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

    FDA Recall
    Terminated ·Clariance Inc·Product code NKB·July 1, 2019

    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

    FDA Enforcement
    Class II ·Ongoing·Clariance-SAS·April 22, 2026