BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5334124 · Received December 30, 2015

    Report

    Report Number
    1030489-2015-03608
    Event Type
    Malfunction
    Date Received
    December 30, 2015
    Date of Event
    September 28, 2015
    Report Date
    December 2, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH 510K NUMBER K020709 AND CATALOG NUMBER 8549305 IS APPROVED FOR SALE IN US. PRODUCT ANALYSIS : VISUAL AND OPTICAL EXAMINATION OF THE RETURNED DOMINO SET SCREW IDENTIFIED DISPLACED MATERIAL MOVEMENT, WITH CIRCULAR WITNESS MARKS INSIDE OF THE HEX, AS WELL AS ROUNDED HEX CORNERS. THE DEFORMATION IS CONSISTENT DOWN THE FULL DEPTH OF THE IMPLANT, SUGGESTING FULL INSERTION OF THE DRIVER DURING USAGE. THE ABOVE FINDINGS ARE CONSISTENT WITH STRIPPING TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY (GROWING ROD) . DURING SURGERY, THE HEX DRIVER WAS STRIPPED WHEN THE SURGEON LOOSED A SCREW OF DOMINO. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. UPON ANALYSIS OF THE RETURNED SET SCREW OF DOMINO, IT WAS FOUND TO BE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859427 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0377471W (X2)

    Patients

    Seq Age Sex Outcome Treatment
    1