BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIANCE IDYS-LLIF 3DTI

    MDR report key: 11994829 · Received June 14, 2021

    Report

    Report Number
    3009962553-2021-00002
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 2, 2021
    Manufacturer
    CLARIANCE SAS
    Product Code
    MAX
    UDI-DI
    03700780634521
    PMA / PMN Number
    K202032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE PLATE CONNECTION PROBLEM, IDYS-LLIF CAGE WAS LEFT IMPLANTED WITH NO PLATE OR SCREWS BY THE SURGEON. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WERE INSERTED POSTERIORLY TO STABILIZE THE CAGE AND THE SEGMENT. HOWEVER, IDYS-LLIF IS INTENDED TO BE USED AS A CONSTRUCT COMPRISED OF ONE CAGE, ONE PLATE AND TWO SCREWS.

    Additional Manufacturer Narrative · 0

    DUE TO THE PLATE CONNECTION PROBLEM, IDYS-LLIF CAGE WAS LEFT IMPLANTED WITH NO PLATE OR SCREWS BY THE SURGEON. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WERE INSERTED POSTERIORLY TO STABILIZE THE CAGE AND THE SEGMENT. HOWEVER, IDYS-LLIF IS INTENDED TO BE USED AS A CONSTRUCT COMPRISED OF ONE CAGE, ONE PLATE AND TWO SCREWS.

    Description of Event or Problem · 0

    SURGEON INSERTED THE CAGE + PLATE ASSEMBLY. HE WAS UNHAPPY WITH THE CAGE POSITION. HE DECIDED TO REMOVE THE CAGE + PLATE ASSEMBLY. WHILE EXTRACTING THE CAGE + PLATE ASSEMBLY AND USING SLAP-HAMMER, THE PLATE DISCONNECTED FROM CAGE. AS A RESULT, CAGE REMAINED IN THE DISC SPACE. AN INSTRUMENT AVAILABLE DURING SURGERY WAS USED TO REMOVE CAGE OUT OF THE DISC SPACE. THE SURGEON RE-INSERTED THE CAGE + PLATE ASSEMBLY AND THE PLATE DISCONNECTED AGAIN. AS A CONSEQUENCE, THE PRODUCT WAS USED WITHOUT PLATE. NO HARM WAS CAUSED TO THE PATIENT. AS ORIGINALLY PLANNED, A POSTERIOR FIXATION WAS USED TO BACK-UP THE CAGE. DELAY IN SURGERY WAS ABOUT 15 MINUTES.

    Description of Event or Problem · 0

    SURGEON INSERTED THE CAGE + PLATE ASSEMBLY. HE WAS UNHAPPY WITH THE CAGE POSITION. HE DECIDED TO REMOVE THE CAGE + PLATE ASSEMBLY. WHILE EXTRACTING THE CAGE + PLATE ASSEMBLY AND USING SLAP-HAMMER, THE PLATE DISCONNECTED FROM CAGE. AS A RESULT, CAGE REMAINED IN THE DISC SPACE. AN INSTRUMENT AVAILABLE DURING SURGERY WAS USED TO REMOVE CAGE OUT OF THE DISC SPACE. THE SURGEON RE-INSERTED THE CAGE + PLATE ASSEMBLY AND THE PLATE DISCONNECTED AGAIN. AS A CONSEQUENCE, THE PRODUCT WAS USED WITHOUT PLATE. NO HARM WAS CAUSED TO THE PATIENT. AS ORIGINALLY PLANNED, A POSTERIOR FIXATION WAS USED TO BACK-UP THE CAGE. DELAY IN SURGERY WAS ABOUT 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893492 CLARIANCE IDYS-LLIF 3DTI LUMBAR INTERVERTEBRAL BODY FUSION DEVICE WITH BONE GRAFT MAX CLARIANCE SAS 51430013-S K678X-K633Y 03700780634521

    Patients

    Seq Age Sex Outcome Treatment
    1