BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2132718 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00750
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    November 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE CROWNS ARE SHOWING IMPACTIONS DUE TO TIGHTENING WITH A SPINAL ROD. THE DEFORMATION IS SYMMETRICAL WHICH IS CONSISTENT WITH PROPER TIGHTENING OF THE CONNECTION. THE RODS WERE CUT IN SEVERAL PIECES AS SHOWN THE DEEPER MARKS COMING FROM A ROD CUTTER. THE TWO PIECES OF ROD WITH A ROUNDED TIP PRESENT TWO MARKS COMING FROM THE SETSCREWS AT THEIR POSTERIOR SIDE: ONE MARK CLOSEST TO THE ROUNDED TIP CORRESPONDING TO THE PRELIMINARY TIGHTENING AND THE OTHER MARK CORRESPONDING TO THE FINAL TIGHTENING. ONE OF THOSE TWO PIECES OF ROD PRESENTS 1 CONTACT WITH THE MAS CROWN AT ITS ANTERIOR SIDE. ONE OTHER PIECE OF ROD PRESENTS 1 MARK COMING FROM THE SETSCREW AT ITS POSTERIOR SIDE. ALL SETSCREWS PRESENT WORN SURFACES AT THE FLAT BOTTOM WHICH ARE CONSISTENT WITH THE TIGHTENING OF THE RODS. NO PRE-EXISTING DEFECT RESPONSIBLE OF THE EVENT HAS BEEN IDENTIFIED ON THE RETURNED IMPLANTS. THE OBSERVATIONS SUGGEST THAT THE RODS HAVE BEEN CONNECTED TO THE MAS PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL FUSION USING POSTERIOR INSTRUMENTATION TO TREAT THORACOLUMBAR-SACRAL KYPHOSCOLIOSIS. AN UNKNOWN TIME POST-OP, IT WAS NOTED THAT THE SCREWS HAD MIGRATED. 186 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE PROXIMAL PORTION OF THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS 75445535 H10H0829

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention