BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISSYS PEDICLE SCREW 6.5 MM X 50 MM

    MDR report key: 1296788 · Received November 26, 2008

    Report

    Report Number
    3005129649-2008-00002
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 25, 2008
    Manufacturer
    CUSTOM SPINE, INC.
    Product Code
    MCV
    PMA / PMN Number
    K043522
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE THAT OVERSAW THE CASE, THE DOCTOR'S OPINION WAS THE FAILURE OCCURRED BECAUSE OF MOVEMENT ALLOWED BY THE PSEUDO ARTHROSIS SEGMENT. AS PER THE RISK COORDINATOR, THE SCREW WAS GIVEN TO THE PATIENT. NO EVALUATION COULD BE PERFORMED ON THE PRODUCT.

    Description of Event or Problem · 1

    AN ISSYS SCREW (CAT 016550, LOT 104823, SIZE 6.5MM X 50MM ) WAS FOUND BROKEN IN L5 DURING A PRE-OP VISIT. THE PATIENT HAD PREVIOUS SPINAL FUSION SURGERY OF L2-L5 IN 2006 AND REPORTED REOCCURRENCE OF BACK PAIN IN 2008. THE DOCTOR DISCOVERED L4-L5 DID NOT HEAL (PSEUDO ARTHROSIS) AND OPTED TO REVISE THE L4-L5 (DATE: 2008).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISSYS PEDICLE SCREW 6.5 MM X 50 MM PEDICLE SCREW MCV CUSTOM SPINE, INC. ISSYS 104823

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other