BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR MEDICAL - EASYSPINE

    MDR report key: 1671221 · Received April 26, 2010

    Report

    Report Number
    3004788213-2009-00004
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    June 8, 2007
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 343886. 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: "THE USE OF 5MM IN DIAMETER SCREWS IN LOWER LUMBAR SPINE, ESPECIALLY WITH A PT OF (B) (6) IS NOT RECOMMENDED. THE INVESTIGATIONS PERFORMED ON THE SCREWS SHOWS NO DEFECTS OF THE MATERIAL. THE FAILURE IS A STANDARD FATIGUE FAILURE DUE TO TOO MUCH IN VIVO LOADS ON THE CONSTRUCT. THE SCREWS ARE MECHANICALLY TESTED AND DESIGNED FOR USE IN THORACIC LUMBAR SPINE, BUT THE SURGEON SHOULD USE THE CORRECT SIZE REGARDING PT ANATOMY & WEIGHT. 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 SIMILAR ISSUES LDR MEDICAL DECIDED TO RELABEL THE 5MM IN DIAMETER SCREWS TO SHOW THAT THEY ARE INTENDED TO BE USE ONLY IN THORACIC SPINE SURGERY."

    Description of Event or Problem · 1

    AFTER 8 MONTHS OF IMPLANTATION, THE SURGEON DISCOVERED THAT THE TWO (2) SCREWS IMPLANTED IN A BI-CORTICAL MANNER IN L5 WERE FRACTURED IN WHAT APPEARED TO BE A FATIGUE FRACTURE. SINCE THE PT WAS STILL IN PAIN, THE SURGEON DECIDED TO REVISED THE CONSTRUCT, HE THEN REMOVED THE BROKEN SCREWS. 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 NA 30787

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention