BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROI-A IMP HOLD THREADED ROD

    MDR report key: 8801590 · Received July 18, 2019

    Report

    Report Number
    3004788213-2019-00237
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 24, 2019
    Report Date
    May 1, 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.

    Description of Event or Problem · 0

    CORRECTIONS TO ALL FIELDS. THIS MDR IS A DUPLICATE OF MDR # 3004788213-2019-00236.

    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 TRACEABILITY AND DEVICES HISTORY RECORDS. PRODUCT WAS NOT RETURNED YET, NO EVALUATION COULD BE PERFORMED. INVESTIGATION STILL IN PROGRESS. NOT RETURNED TO MANUFACTURER YET.

    Description of Event or Problem · 1

    ROI-A: BROKEN INSTRUMENT. ACCORDING TO THE DESCRIPTION PROVIDED , A 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 TOGETHER. THEY BURRED PORTIONS OF THE ANTERIOR FACE OF THE IMPLANT PER THE SURGICAL TECHNIQUE AND REMOVED THE BLADES, THEN THEY USED A KOCHER TO REMOVE THE CAGE. THE THREADED ROD WAS NOT COMING OUT OF THE IMPLANT HOLDER SO THE TECH ASSEMBLED THE RADD DELIVERY SYSTEM TO IMPLANT THE NEW CAGE. FOLLOWING THE SURGICAL TECHNIQUE THE NEW CAGE/BLADES WERE IMPLANTED. ALL TOGETHER THE CASE WAS DELAYED AROUND 40-45 MINS. NO PATIENT COMPLICATION WAS NOTIFIED. ADDITIONAL INFORMATION AND PRODUCT RETURN WERE REQUESTED. INVESTIGATION STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595314 ROI-A IMP HOLD THREADED ROD INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT OVD LDR MÉDICAL N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other