BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR MEDICAL - EASYSPINE

    MDR report key: 1671220 · Received April 26, 2010

    Report

    Report Number
    3004788213-2009-00005
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    September 11, 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
    BR
    Reporter Occupation
    NOT APPLICABLE

    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 (B) (4) AND ARE SUBMITTING THE UPDATED FORM FDA 3500A, ENCLOSED WITH THE ORIGINAL REPORT SUBMITTED, PER OUR CONVERSATION WITH (B) (4) AND (B) (4). THE CONSTRUCT IMPLANTED USED TWO (2) PEDICLE SCREWS OF 5MM IN DIAMETER IN S1. THIS DIAMETER IS NOT CORRECT FOR SUCH LOWER LEVELS ACCORDING TO STATE OF THE ART SPINE SURGERY. FURTHERMORE, THE TIMELINE SHOWS THE PT WAS EXPERIMENTING PROBABLY A CASE OF PSEUDARTHROSIS, SINCE ONE YR AFTER SURGERY, THE FUSION SHOULD HAVE OCCURRED AND THEN THE CONSTRUCT WOULD NOT BROKE. IN ORDER TO FURTHER USAGE OF THE DIAMETER 5 IN LUMBAR SPINE FIXATION, LDR MEDICAL DECIDED TO MODIFY THE LABELING TO SHOW THAT THE 5MM SCREWS ARE ONLY INTENDED FOR USE IN THORACIC SPINE.

    Description of Event or Problem · 1

    ONE YR AFTER SURGERY, PT WAS STILL HAVING PAIN AND DECIDED TO PROCEED TO RADIOLOGICAL EXAM. THE LOWER SCREWS (IN S1) WERE DISCOVERED BROKEN. HER SURGEON HAS DECIDED TO REVISE THE CONSTRUCT, SINCE THE PT WAS STILL IN PAIN. 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 FRANCE. 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 PEDICLE SCREWS MNI LDR MEDICAL NA 30780

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention