BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2180649 · Received July 27, 2011

    Report

    Report Number
    1030489-2011-00948
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    November 2, 2011
    Manufacturer
    WARSAW ORTHOPEDICS, INC.
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT BOTH RODS PRESENT SEVERAL MARKS COMING FROM THE SETSCREWS AT THEIR POSTERIOR SIDE: SMALL MARKS CORRESPONDING TO THE PRELIMINARY TIGHTENING AND LARGER MARKS CORRESPONDING TO THE FINAL TIGHTENING. BOTH RODS PRESENT 2 CONTACTS WITH THE MAS CROWN AT ITS ANTERIOR SIDE. ALL SETSCREWS PRESENT WORN SURFACES AT THE FLAT BOTTOM WHICH ARE CONSISTENT WITH THE TIGHTENING OF THE RODS. NO PRE-EXISTING DEFECT HAS BEEN IDENTIFIED ON THE RETURNED IMPLANTS. THE OBSERVATIONS SUGGEST THAT THE RODS HAVE BEEN CONNECTED PROPERLY TO THE MAS. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L3-L4 SPINAL FUSION TO TREAT DEGENERATIVE DISC DISEASE AND CANCER. AN UNKNOWN TIME POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS, INC. 8690040 W07G2058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention