BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

    MDR report key: 16255788 · Received January 27, 2023

    Report

    Report Number
    3004788213-2023-00005
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 4, 2023
    Report Date
    April 25, 2024
    Manufacturer
    LDR MÉDICAL
    Product Code
    MAX
    PMA / PMN Number
    SEEH10
    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

    PMA/510K: 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. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN G1. ADDITIONAL INFORMATION IN H6: 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 BOTH OF THE ANCHORING PLATES BEING INSTALLED IN THE BOTTOM HOLE OF THE IMPLANT HOLDER. DHR REVIEW: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED, THEREFORE A DHR IS UNABLE TO BE LOCATED FOR REVIEW. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH ROI-A ANCHOR PLATES WERE INSTALLED IN THE BOTTOM HOLE OF THE IMPLANT HOLDER AND THE CAGE BROKE. A NEW CAGE AND ANCHOR PLATES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 10 MINUTES WITHOUT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH ROI-A ANCHOR PLATES WERE INSTALLED IN THE BOTTOM HOLE OF THE IMPLANT HOLDER AND THE CAGE BROKE. A NEW CAGE AND ANCHOR PLATES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 10 MINUTES WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431534 ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM ROI-A ALIF CAGE SYSTEM MAX LDR MÉDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose IR2008T, LOT NI.