BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER CERVICAL PLATING SYSTEM

    MDR report key: 9739912 · Received February 21, 2020

    Report

    Report Number
    3005031160-2020-00005
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 21, 2020
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    UDI-DI
    M697N600001371
    PMA / PMN Number
    K052292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINANT COMMUNICATED TO THE COMPANY ON (B)(6) 2020 THAT A FRACTURED IMPLANT SCREW WAS IDENTIFIED BY X-RAY PRIOR TO PERFORMING A REVISION PROCEDURE ON (B)(6) 2020. THE FRACTURED SCREW POSED NO PROBLEMS TO THE PATIENT AND WAS NOT THE REASON FOR REVISION. THE REVISION PROCEDURE WAS BEING PERFORMED DUE TO NON-FUSION AND ADJACENT LEVEL SYNDROME, WHICH ADDED HARDWARE TO THE ADJACENT LEVEL AND WAS BACKED UP POSTERIORLY. THE COMPLAINANT RETURNED THE FRACTURED SCREW TO THE COMPANY ON (B)(6) 2020. A DHR REVIEW WAS PERFORMED FOR LOT# 170748 AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 6/15/2015. THE ORIGINAL C5-C7 PROCEDURE WAS PERFORMED ON (B)(6) 2015. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT REPORTED. THE REVISION PROCEDURE TO EXTEND TO ADJACENT LEVEL DUE TO NON-FUSION WAS PERFORMED ON (B)(6) 2020. IN THE WARNINGS SECTION OF THE SYSTEM IFU IT STATES, "INTERNAL FIXATION DEVICES CANNOT WITHSTAND ACTIVITY AND LOAD LEVELS EQUAL TO THOSE PLACED ON NORMAL HEALTHY BONE. UNTIL MATURATION OF THE FUSION MASS IS CONFIRMED DO NOT SUBJECT THIS DEVICE TO THE STRESS OF FULL WEIGHT BEARING, OR IMPLANT FAILURE MAY RESULT". THE POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS SECTION OF THE IFU LISTS "EARLY OR LATE LOOSENING OF ANY OR ALL OF THE COMPONENTS; DISASSEMBLY, BENDING, AND/OR BREAKAGE OF ANY OR ALL OF THE COMPONENTS; AND NON-UNION (PSEUDARTHROSIS), DELAYED UNION, MAL-UNION." AS POSSIBLE EFFECTS AND COMPLICATIONS FOR THE SURGICAL SYSTEM. A LACK OF SOLID FUSION CAN RESULT IN INCREASED STRESS ON IMPLANTS AND MAY RESULT IN IMPLANT FAILURE. IT IS UNKNOWN WHEN AND HOW THE SYSTEM SCREW FRACTURED.

    Description of Event or Problem · 1

    A COMPLAINANT COMMUNICATED TO THE COMPANY ON (B)(6) 2020 THAT A FRACTURED IMPLANT SCREW WAS IDENTIFIED BY X-RAY PRIOR TO PERFORMING A REVISION PROCEDURE ON (B)(6) 2020. THE FRACTURED SCREW POSED NO PROBLEMS TO THE PATIENT AND WAS NOT THE REASON FOR REVISION. THE REVISION PROCEDURE WAS BEING PERFORMED DUE TO NON-FUSION AND ADJACENT LEVEL SYNDROME, WHICH ADDED HARDWARE TO THE ADJACENT LEVEL AND WAS BACKED UP POSTERIORLY. THE COMPLAINANT RETURNED THE FRACTURED SCREW TO THE COMPANY ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205073 SPIDER CERVICAL PLATING SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ X-SPINE SYSTEMS, INC. N60000137 170748 M697N600001371

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other