BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR MEDICAL - EASYSPINE

    MDR report key: 1671223 · Received April 26, 2010

    Report

    Report Number
    3004788213-2009-00002
    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
    K043494
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: ES507T(2); EXP DATE: 04/01/2012. ADDITIONAL MFR DATE: 04/2007. 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).

    Description of Event or Problem · 1

    THE RIGHT SIDE OF THE CONSTRUCT DISASSEMBLED OVERTIME LEADING TO A REVISION SURGERY FOR A PARTIAL REMOVAL OF THE OSTEOSYNTHESIS ASSEMBLY. LDR MEDICAL MADE MANY ATTEMPTS TO OBTAIN FURTHER INFO FROM THE SURGEON SUCH AS XRAYS AND A SURGERY REPORT, BUT NO ANSWER CAME THROUGH EXCEPT THE REMOVED IMPLANTS. EVAL OF THE REMOVED IMPLANTS IT WAS DETERMINED THAT THE CONSTRUCT WAS NOT TIGHTEN ENOUGH TO ACHIEVE ITS STANDARD PERFORMANCES. THIS OCCURRENCE IS THE FIRST ONE AS ACKNOWLEDGED BY LDR MEDICAL AND IS THEN CONSIDERED AS AN ISOLATED INCIDENT DUE TO A SURGICAL ERROR. 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 PEDICLE SCREW CONSTRUCT MNI LDR MEDICAL EASYSPINE 356877/349423/16694

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention