BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACET FIXATION SYSTEM

    MDR report key: 1692532 · Received May 12, 2010

    Report

    Report Number
    3004744230-2010-00002
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 12, 2010
    Manufacturer
    US SPINE INC.
    Product Code
    MRW
    PMA / PMN Number
    K061041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STILL AWAITING RETURN OF MEDICAL DEVICE, MORE EVALUATION WILL BE PROVIDED IN FOLLOW UP.

    Description of Event or Problem · 1

    RECEIVED E-MAIL FROM OUR AREA SALES DIRECTOR INDICATING COMMUNICATION WITH A PHYSICIAN REGARDING A L4-S1 REVISION CASE. PATIENT WAS EXPERIENCING LEG PAIN. PHYSICIAN PERFORMED A L4-S1 FACET BOLT REVISION CASE. L5-S1 FACET BOLT CAME APART IN-SITU. THE OTHER L4-L5 BOLT WAS LOOSE ENOUGH FOR PHYSICIAN TO MOVE BOLT ANTERIORLY AND POSTERIORLY THROUGH THE FACET JOINT. AFTER REMOVING THE BOLTS THE PHYSICIAN PROCEEDED TO REMOVE THE FACETS COMPLETELY RELEASING THE EXITING NERVES AT BOTH LEVELS COMPLETELY AND PLACED 3 PEDICLE SCREWS AND 70MM PRE-LORDORSED ROD AND 3 SET SCREW LOCKING CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACET FIXATION SYSTEM NONE MRW US SPINE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention