BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISSYS PEDICLE SCRE SYSTEM

    MDR report key: 2519743 · Received April 3, 2012

    Report

    Report Number
    3005129649-2012-00001
    Event Type
    Other
    Date Received
    April 3, 2012
    Report Date
    March 30, 2012
    Manufacturer
    CUSTOM SPINE, INC.
    Product Code
    KWP
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR RETURNED ALL 22 PIECES TO CUSTOM SPINE ON 03/06/2012. IT APPEARS THAT PATIENT SUFFERED A SUBSTANTIAL FALL THAT RESULTED IN BREAKAGE OF THE ROD (CAT #047600, LOT #F052) IN THREE DIFFERENT LOCATIONS. BASED ON THE CT IMAGE, IT APPEARS THAT THE ROD FRACTURES OCCURRED IN THE L4-S1 AREA. THE FALL HAD ALSO CONTRIBUTED TO A DISASSEMBLED SCREW (CAT # 045550, LOT # F063). THE BONE SCREW COMPONENT CAME APART FROM THE SCREW HEAD. FLANGES OF THE SCREW HEAD'S SPHERICAL COLLECT BROKE AWAY RESULTING IN THE DISASSEMBLY OF THE SCREW HEAD AND BONE SCREW. ATTACHED TO THE ROD IS A SCREW THAT HAD A PARTIALLY FRACTURED BLOCKER STILL ATTACHED TO IT (CAT # 043000, LOT # UNK UNLESS MANUALLY DISASSEMBLED). THERE ARE NO OTHER DAMAGED PRODUCTS. A THOROUGH REVIEW OF DEVICE HISTORY RECORDS WAS COMPLETED. AFTER PERFORMING A THOROUGH INVESTIGATION AND SPEAKING TO DISTRIBUTOR, IT IS APPEARS THAT THE DAMAGE TO PRODUCT IS RELATED TO THE FALL THAT THE PATIENT HAD SUFFERED FROM. THE SEVERE NATURE OF THE SUBSTANTIAL FALL IS MOST LIKELY THE ROOT CAUSE OF THE DAMAGE TO THE PRODUCT. THE TRAUMATIC SHOCK LOADING COULD BE DETRIMENTAL TO ANY LONG ROD CONSTRUCT.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A SUBSTANTIAL FALL THAT RESULTED IN BROKEN HARDWARE AND A FRACTURED FEMUR. THIS WAS A LONG CONSTRUCT ON THE LEFT SIDE (T4-ILIAC). THERE WERE MULTIPLE ROD FRACTURES; TWO SCREW HEADS THAT CAME APART FROM THE SCREW, BOTH ARE STILL ATTACHED TO THE ROD. ONE SCREW HEAD IS BROKEN AT THE SPHERICAL COLLET AND THE OTHER CONTAINS A BROKEN BLOCKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISSYS PEDICLE SCRE SYSTEM PEDICLE SCREW KWP CUSTOM SPINE, INC. NA F052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other