BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

    MDR report key: 8539705 · Received April 23, 2019

    Report

    Report Number
    3004788213-2019-00115
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 23, 2020
    Manufacturer
    LDR MÉDICAL
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D2 (COMMON DEVICE NAME): THIS DEVICE IS NOT CLEARED IN THE US, BUT IT IS SIMILAR TO AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM, ROI-T IMPLANT SYSTEM. G5 (510K NUMBER): THIS DEVICE IS NOT FOR USE WITHIN THE US, BUT IT IS SIMILAR TO K153495. H3: INFORMATION WAS ENTERED IN ERROR; ONLY THE CHECK BOX FOR 'NOT RETURNED TO MANUFACTURER' SHOULD BE CHECKED. THE IMPLANT WAS NOT RETURNED FOR EVALUATION, SO NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. A REVIEW OF THE DHR DID NOT FIND ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE'S LABELING PROVIDES INSTRUCTIONS REGARDING PROPER DEVICE USAGE AND INSTALLATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CAGE WAS REPLACED WITH A DEVICE WITH MORE LORDOSIS AFTER BEING UNABLE TO INSTALL THE ANCHORING PLATES DUE TO THE CAGE'S POSITION WITHIN THE DISC SPACE. THERE WERE NO REPORTED PATIENT IMPACTS.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS SUBMITTED TO SEND THE INITIAL REPORT THIS COMPLAINT. THE REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATIONS OR DEVIATIONS IN PROCEDURES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT THE PRODUCT WILL NOT BE RETURNED TO THE MANUFACTURER . THEREFORE, NO PRODUCT EVALUATION COULD BE PERFORMED. INVESTIGATION STILL IN PROGRESS. CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 1

    ROI-A: SPONDYLOPTOSIS, IMPOSSIBLE TO USE ANCHORING PLATE. A SALES REPRESENTATIVE REPORTED ON (B)(6) 2019 THAT A ROI-A SURGERY WAS DIFFICULT. A DIFFERENT IMPLANT WAS IMPLANTED DURING SURGERY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: A PATIENT HAD SPONDYLOPTOSIS. AFTER SEVERAL ATTEMPTS, THE SURGEON CHOSE AN INSET IMPLANT. WHEN DEVICE WAS IMPLANTED, THE SURGEON COULD NOT USED THE ANCHORING PLATES BECAUSE THEY WERE TOO CLOSE TO THE ANTERIOR WALL OF THE SACRUM. CONSEQUENTLY, THE SURGEON DECIDED TO REMOVE THE CAGE AND USE ANOTHER DEVICE WITH MORE LORDOSIS (NOT LDR DEVICE). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THE PATIENT IS DOING WELL AND WAS RELEASED FROM HOSPITAL. THE PRODUCT WILL NOT BE RETURNED. NO X-RAY IMAGES WILL BE PROVIDED. NO DELAY OVER 30 MINUTES WAS REPORTED. THE REPORTER COULD NOT DETAIL THE PATIENT'S INITIAL INDICATIONS TO SURGERY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THE ROI-A STERILE STARTER AWL FOR ANCHORING PLATE WAS AVAILABLE DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333948 ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14 SEE H10 MAX LDR MÉDICAL N/A 16-117802

    Patients

    Seq Age Sex Outcome Treatment
    1