BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLORADO II SPINAL SYSTEM

    MDR report key: 2621188 · Received June 19, 2012

    Report

    Report Number
    1030489-2012-01007
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K0991031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IMPLANTS OF MULTIPLE PART/LOT NUMBERS WERE USED IN THIS CASE. PART G8630430, LOT W08E0863 / PART G8630435, LOT W08F0983 / PART G8630440, LOT W07C3310 / PART G8630440 LOT W07D3071. ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFCATION PURPOSES. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 8630430, 8630435, AND 8630440 AND 510K # K031655 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    A REVIEW OF ALL DOCUMENTS INCLUDED IN THE DHR FOR LOTS W08E0863, W08F0983, W07C3310, AND W07D3071 DID NOT IDENTIFY ANY APPLICABLE NO N-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE. A QUERY OF THE ENTIRE COMPLAINT HISTORY OF THESE PARTS WAS CONDUCTED ON (B)(6) 2012, WHICH DID NOT CONTRIBUTE ANY ADDITIONAL INFORMATION TO THIS INVESTIGATION. (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

    SURGERY DATE: (B)(6) 2010. A (B)(6) FEMALE UNDERWENT A PROCEDURE AT TH12-L3 TO TREAT L2 BURST FRACTURE. IT WAS REPORTED THAT AFTER COMPLETION OF BONE FUSION, BREAKAGE OF RIGHT L3 SCREW WAS CONFIRMED. THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2012. THE RIGHT L3 SCREW WAS BROKEN AT THE MIDDLE OF PEDICLE WHERE WAS TOO NARROW TO REMOVE THE FRAGMENT. THE SURGEON DECIDED TO LEAVE THE FRAGMENT TO CONSERVE THE PEDICLE. THE OTHER DEVICES WERE REMOVED SUCCESSFULLY. NO ADDITIONAL PATIENT COMPLICATION IS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE AT TH12-L3 TO TREAT L2 BURST FRACTURE. AFTER THE BONE HAD COMPLETELY FUSED, IT WAS FOUND / CONFIRMED THAT THE RIGHT L3 SCREW WAS BROKEN. THE PATIENT UNDERWENT REMOVAL SURGERY. DURING SURGERY, THE DOCTOR FOUND THE RIGHT L3 SCREW HAD BROKEN AT THE MIDDLE OF THE PEDICLE WHERE IT WAS TOO NARROW TO REMOVE THE FRAGMENT. THE SURGEON DECIDED TO LEAVE THE DEVICE FRAGMENT TO CONSERVE THE PEDICLE. THE OTHER DEVICES WERE REMOVED SUCCESSFULLY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO II SPINAL SYSTEM KWQ WARSAW ORTHOPEDICS G8630430 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention