BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1902408 · Received November 18, 2010

    Report

    Report Number
    1030489-2010-01476
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEPTION OF THE LOANER KIT, THE INSTRUMENT HAS BEEN SEGREGATED FOR DECONTAMINATION AND CONTROL PROCESS. NO DAMAGE HAS BEEN OBSERVED AT THE LEVEL OF THE ROD CONNECTION TIP. THE INSTRUMENT HAS BEEN TESTED FOR ASSEMBLY WITH A SAMPLE ROD AND WAS FOUND TO HOLD THE ROD PROPERLY. THE OBSERVATION OF THE PART RETURNED DID NOT IDENTIFY ANY DAMAGE, THE INSTRUMENT WAS FOUND TO WORK AS INTENDED. THE EVENT CAN BE ATTRIBUTED TO A WRONG ASSEMBLY OF THE SPINAL ROD WITH THE ROD INSERTER PRIOR TO THE IMPLANTATION. IT IS REMINDED TO FULLY MANEUVER THE OPENING / CLOSING MECHANISM OF THE ROD INSERTER TO ENSURE THE ROD IS PROPERLY CAPTURED AND HELD BY THE INSERTER.

    Additional Manufacturer Narrative · 1

    THE INSERTER HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY-INVASIVE DOUBLE LEVEL SPINAL FUSION PROCEDURE IT WAS IMPOSSIBLE TO INSERT THE ROD IN THE PROXIMAL TULIP. CHECKING INTRA-OP WITH THE FLUOROSCOPY THE ROD DEVIATED FROM THE IDEAL TRACK DUE TO THE CONNECTION BETWEEN THE INSERTER AND THE ROD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. ASKU M05J0019

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR