BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2182428 · Received July 28, 2011

    Report

    Report Number
    1030489-2011-00960
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 21, 2011
    Report Date
    November 2, 2011
    Manufacturer
    WARSAW ORTHOPEDICS, INC.
    Product Code
    KWP
    PMA / PMN Number
    K052747
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT ALL FAS PRESENT 2 MARKS AT THE BOTTOM OF THE ROD CANAL COMING FROM THE ROD. BOTH RODS PRESENT 2 MARKS COMING FROM THE SETSCREWS AT THEIR POSTERIOR SIDE AND 2 CONTACTS WITH THE FAS ROD CANAL 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 FAS.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6) 2008. (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 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 UNKNOWN PROCEDURE TO TREAT OSTEOSYNTHESIS IN PATHOLOGICAL FRACTURE DUE TO METASTATIC BREAST CANCER AT T7 LEVEL. SCREW MIGRATION OCCURRED AND IS THOUGHT TO BE DUE TO THE PATIENT HAVING CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS, INC. NA W07A3215

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention