BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-A IMPLANT HOLDER

    MDR report key: 8825393 · Received July 25, 2019

    Report

    Report Number
    3004788213-2019-00246
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 24, 2019
    Report Date
    February 14, 2020
    Manufacturer
    LDR MÉDICAL
    Product Code
    OVD
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO ALL FIELDS:THIS MDR IS A DUPLICATE OF MDR # 3004788213-2019-00236-1.ALL NON-REQUIRED FIELDS HAVE BEEN CLEARED OF DATA.

    Description of Event or Problem · 0

    THIS MDR IS A DUPLICATE OF MDR # 3004788213-2019-00236-1.ALL NON-REQUIRED FIELDS HAVE BEEN CLEARED OF DATA.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS SUBMITTED TO SEND THE INITIAL REPORT OF THIS COMPLAINT. LOT NUMBER OF CONCERNED DEVICE IS NOT KNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE AND NO ANSWER HAS BEEN PROVIDED YET. SO FAR, IS NOT POSSIBLE TO PERFORM THE REVIEW OF TRACEBAILITY AND DEVICES HISTORY RECORDS. PRODUCT WAS NOT RETURNED YET, NO EVALUATION COULD BE PERFORMED. INVESTIGATION STILL IN PROGRESS.

    Description of Event or Problem · 1

    ROI-A: IR9280R DEVICE MALFUNCTION. ACCORDING TO THE DESCRIPTION RECEIVED, DURING A ROI-A SURGERY , IMPLANT HOLDER COTTER PIN CAME APART AND FELL INTO THE WOUND. IT WAS RETRIEVED AND TAKEN OUT OF PATIENT. THE THREADED ROD STRIPED OUT OF THE IMPLANT SO IT COULD NOT BE CONTROLLED. THE SHAFT OF THE INSERTER BROKE OFF THE WING GUIDE SO EVERYTIME THE SURGEON HIT IT WITH A MALLET IT BENT OVER THE GUIDE MAKING IT IMPOSSIBLE TO DEPLOY THE BLADE AFTER MANY ATTEMPTS, THE DOCTOR DECIDED IT WAS BEST TO REMOVE THE BLADE AND CAGE AN TOGETHER. THEY BURRED PORTIONS OF THE ANTERIOR FACE OF THE IMPLANT PER THE SURGICAL TECHNIQUE AND REMOVED THE CAGE . THIS REPORT IS ABOUT THE INSTRUMENT BREAKAGE. THE THREADED ROD WAS NOT COMING OUT OF THE IMPLANT HOLDER SO THE TECH ASSEMBLED THE RADD DELIVERY SYSTEM TO IMPLANT THE NEW CAGE AND BLADES. FOLLOWING THE SURGICAL TECHNIQUE THE NEW CAGE AND BLADES WERE IMPLANTED ALL TOGETHER THE CASE WAS DELAYED AROUND 40-45. THE PATIENT WAS NOT HARMED IN ANY WAY DURING THIS PROCEDURE. THE REPORTED LOT FOR INSTRUMENT WAS NOT FOUND IN OUR RECORDS. CLARIFICATION REQUESTED. INVESTIGATION ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619419 ROI-A IMPLANT HOLDER INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT OVD LDR MÉDICAL N/A NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other