BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

    MDR report key: 16925970 · Received May 13, 2023

    Report

    Report Number
    3004788213-2023-00044
    Event Type
    Malfunction
    Date Received
    May 13, 2023
    Date of Event
    April 18, 2023
    Report Date
    April 25, 2024
    Manufacturer
    LDR MÉDICAL
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS. ADDITIONAL INFORMATION: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OFF-AXIS FORCES APPLIED ON THE CAGE DURING ANCHORING PLATE INSERTION OR THE PATIENT HAVING HARD BONE. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE CONTROL. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS NOT CLEARED FOR USE IN OR MARKETED WITHIN THE US, HOWEVER IT IS A SIMILAR PRODUCT TO THOSE CLEARED BY K153495 UNDER PRODUCT CODE MAX. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ROI-A CAGE DID NOT THREAD CORRECTLY ONTO THE IMPLANT HOLDER, AND THEN FRACTURED WHILE THE SURGEON WAS INSTALLING THE ANCHORING PLATE INTRAOPERATIVELY. THE SURGEON DID NOT USE THE AWL PRIOR TO ATTEMPTING TO INSTALL THE PLATE. THE CAGE WAS REMOVED AND REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED WITH NO IMPACTS TO THE PATIENT; THE CAGE WAS DISCARDED BY THE OPERATING ROOM STAFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ROI-A CAGE DID NOT THREAD CORRECTLY ONTO THE IMPLANT HOLDER, AND THEN FRACTURED WHILE THE SURGEON WAS INSTALLING THE ANCHORING PLATE INTRAOPERATIVELY. THE SURGEON DID NOT USE THE AWL PRIOR TO ATTEMPTING TO INSTALL THE PLATE. THE CAGE WAS REMOVED AND REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED WITH NO IMPACTS TO THE PATIENT; THE CAGE WAS DISCARDED BY THE OPERATING ROOM STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357679 ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM ROI-A ALIF CAGE SYSTEM MAX LDR MÉDICAL NA L222751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose