BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAST QUADRANT RETRACTOR SYSTEM

    MDR report key: 10733680 · Received October 26, 2020

    Report

    Report Number
    1030489-2020-01482
    Event Type
    Injury
    Date Received
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    FSZ
    UDI-DI
    00885074042497
    PMA / PMN Number
    K043602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR SPONDYLOLIS THESIS INVOLVED IN OLIF+PPS PROCEDURE USED IN SPINAL THERAPY. LEVELS IMPLANTED: L4/5. IT WAS REPORTED DURING USE, SUPERIOR ADJACENT SEGMENT DISEASE IN PATIENT WAS REPORTED. THERE WAS NO MALFUNCTION OF THE PRODUCT REPORTED. THE BONE WAS FRAGILE ORIGINALLY BECAUSE OF STEROIDS, RHEUMATISM OR DIALYSIS. REMOVAL OF ROD AND SET SCREW WAS PLANNED ON (B)(6) 2020. THERE WAS NO PLAN TO REMOVE CAGE IN REVISION SURGERY. QUANTITY-2 SCREWS WERE REMOVED ON L5, BUT LOT# IS UNKNOWN. THERE WAS NO MALFUNCTION OF IMPLANTED PRODUCTS. OLIF WAS PERFORMED ON L4/5, POSTERIOR SENTANT WAS PERFORMED. DUE TO ADJACENT SEGMENT DISEASE ON L3/4, IT WAS PLANNED TO PERFORM OLIF ON L3/4 AND INSERT PPS IN L3 AND PERFORM CONNECTION ON L3-5 ON (B)(6). ADDITIONAL INFORMATION REGARDING THE RE-OPERATION: BONE FUSION WAS ACHIEVED COMPLETELY ON L4/5, SCREW ON L5 WAS REMOVED. OLIF WAS PERFORMED BETWEEN L3/4, POSTERIOR FUSION ON L3/4 WITH PPS WAS PERFORMED AND THE OPERATION WAS COMPLETED. PATIENT STATUS IS UNKNOWN, BUT MOVEMENT OF LEG RIGHT AFTER THE OPERATION WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200525 MAST QUADRANT RETRACTOR SYSTEM LIGHT, SURGICAL, CARRIER FSZ WARSAW ORTHOPEDICS 9560658 0311534W 00885074042497

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention