BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2940395 · Received February 3, 2013

    Report

    Report Number
    1030489-2013-00355
    Event Type
    Injury
    Date Received
    February 3, 2013
    Date of Event
    November 16, 2012
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECT WAS FOUND ON THE RETURNED IMPLANTS WHICH COULD BE RESPONSIBLE OF THE EVENT. THE EXACT CAUSE OF THE SETSCREWS LOOSENING CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION. THE LOOSENING OF THE SETSCREW MAY COME FROM: - OVER TIGHTENING OF THE SETSCREW AFTER THEIR BREAK OFF LEADING TO THE SPLAY OF THE BONE SCREW TULIP - IMPROPER INSERTION OF THE ROD INTO THE ROD CANAL OF THE PEDICLE SCREW: IN SUCH CONDITION, WHEN THE PATIENT STANDS UP, REALIGNMENT OF THE ROD INTO THE ROD CANAL MAY HAPPEN INDUCING SETSCREW LOOSENING - OVERLOADING OF THE CONSTRUCT DUE TO THE COLLAPSE OF THE FRACTURED LEVEL (AS DESCRIBED IN THE EVENT) WHICH IS CONSISTENT WITH ASYMMETRICAL DEFORMATION OF THE MAS CROWN DUE TO CONTACT WITH THE ROD.

    Additional Manufacturer Narrative · 1

    CT AXIAL VIEW SHOWS DISSCONNECT OF SET SCREW AND TULIP WITH ROD IN CROSS SECTION PARTIALLY UNSEATED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. PATIENT SHOWED SIGNED OF SPONDYLODESIS WITH A BIT OF KYPHOSIS. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT THE SETSCREW WAS LOOSE. A REVISION WAS DONE TO REMOVE THE LOOSE SCREW AND IT WAS DISCOVERED THAT THE PATIENT HAD A WOUND INFECTION. PATIENT WAS TREATED WITH SEVERAL WEEKS OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45747 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H12B2657

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR