BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDYS ALIF

    MDR report key: 8661195 · Received June 1, 2019

    Report

    Report Number
    3009962553-2019-00001
    Event Type
    Malfunction
    Date Received
    June 1, 2019
    Date of Event
    March 1, 2019
    Report Date
    June 1, 2019
    Manufacturer
    CLARIANCE SAS
    Product Code
    OVD
    PMA / PMN Number
    K172083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE ABSENCE OF THE PRODUCT, CLARIANCE CAN NOT GO AHEAD IN ITS INVESTIGATION. THE EXACT REASONS FOR THIS INCIDENT REMAIN UNDETERMINED. HOWEVER CLARIANCE SUSPECTS THAT A BAD INSERTION OF THE SCREW IS THE CAUSE OF THIS ISSUE. INDEED A SIMILAR CASE HAPPENED IN (B)(6) AND FOR WHICH A CORRECTIVE ACTION WAS PUT IN PLACE. INDEED, A TIPS AND TRICKS WAS MADE TO EXPLAIN HOW TO INSERT THE SCREW IN THE PLATE WITHOUT EXPLODING THE SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT DURING IDYS ALIF SURGERY IN LEVEL L4-L5, UPON FINAL TIGHTENING OF THE SCREW, THE SLEEVE CAME OUT OF THE PLATE. THE SLEEVE WAS RETRIEVED AND DISPOSED BY THE SURGEON . AS A CONSEQUENCE, 3 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WERE INSERTED POSTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454611 IDYS ALIF LUMBAR INTERVERTEBRAL BODY FUSION OVD CLARIANCE SAS 24430018-S I752C-IA10Y

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR