BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR MEDICAL - EASYSPINE

    MDR report key: 1671222 · Received April 26, 2010

    Report

    Report Number
    3004788213-2009-00003
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    May 15, 2008
    Report Date
    June 23, 2009
    Manufacturer
    LDR MEDICAL
    Product Code
    MNI
    PMA / PMN Number
    K063749
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED FORM - THE INITIAL REPORT WAS SENT ON 05/29/2009. NO NEW PT, EVENT OR DEVICE INFO HAS BEEN REVISED SINCE THE ORIGINAL MDR SUBMISSION. WE HAVE SPOKEN TO RSMB AND ARE SUBMITTING THE UPDATED FORM FDA 3500A, ENCLOSED WITH THE ORIGINAL REPORT SUBMITTED, PER OUR CONVERSATION WITH (B) (4) AND (B) (4). ADDITIONAL INFO FROM USER FACILITY REPORT: FROM LDR MEDICAL: "AFTER CHECKING ON X RAYS, THE MFR DISCOVERED THAT THESE SCREWS WERE USED IN LOWER LUMBAR SPINE. THIS USAGE OF SUCH A SMALL DIAMETER LUMBAR IS NOT ADEQUATE ACCORDING TO STATE OF THE ART. FURTHERMORE, LOOKING AT THE TIMELINE OF THE EVENT, IT CAN BE SAID THAT THE PT IS EXPERIENCING PSEUDARTHROSIS, THIS CONDITION LEAD TO BREAKAGE OF THE SCREWS IN MOST CASES. THE SCREWS WERE ALSO USED AS BI-CORTICAL, WHICH IS PUTTING MORE STRESSES ON THE SCREWS. THE RESULTS OF THE LDR MEDICAL INVESTIGATION IS THAT THIS ISSUE IS RELATED TO A WRONG USAGE OF THE DEVICE. IN ORDER TO PREVENT FURTHER ISSUES, LDR MEDICAL DECIDED TO MODIFY THE LABELING OF THE SCREWS IN ORDER TO MENTION THAT THIS SCREWS ARE DESIGNED TO BE USED IN THORACIC SPINE."

    Description of Event or Problem · 1

    THREE PEDICLE SCREWS IMPLANTED IN LOWER SPINE WERE BROKEN WHEN PT CAME BACK TO SURGEON 14 MONTHS AFTER SURGERY. THE ABOVE INFO WAS PROVIDED TO LDR SPINE USA BY LDR MEDICAL IN ORDER TO CREATE THIS REPORT. THE EVENT OCCURRED OUTSIDE THE USA AND WAS REPORTED TO LDR MEDICAL IN (B) (4). THIS REPORT IS FOLLOWING AN INTERNAL REVIEW OF COMPLAINTS AT LDR MEDICAL FOR MDR REPORTING STATUS. AFTER REVIEW, IT WAS DETERMINED THAT THIS EVENT MEETS THE CRITERIA FOR A REPORTABLE EVENT IN THE USA. THE INFO HAS BEEN TRANSMITTED TO LDR SPINE FOR REPORTING BY THE QA MGR. LDR SPINE WAS NOTIFIED OF THIS EVENT ON 06/23/2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LDR MEDICAL - EASYSPINE POSTERIOR PEDICLE SCREW MNI LDR MEDICAL EASYSPINE 31343

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention