BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABO ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 10190199 · Received June 24, 2020

    Report

    Report Number
    3012120772-2020-00043
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 23, 2020
    Manufacturer
    SEASPINE INC.
    Product Code
    KWQ
    UDI-DI
    10889981160913
    PMA / PMN Number
    K173521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT ANTERIOR CERVICAL FIXATION CONSISTING OF THE CABO ANTERIOR CERVICAL PLATE SYSTEM. SEASPINE WAS INFORMED OF A REVISION SURGERY THAT OCCURRED ON (B)(6) 2020 AS A RESULT OF A POSTOPERATIVE SCREW MIGRATION. THE CASE SHEETS FROM BOTH THE INDEX SURGERY AND REVISION SURGERY WERE ANALYZED BY PRODUCT MONITORING ALONG WITH THE INFORMATION RECEIVED BY THE DISTRIBUTOR; THE 81-1614 VARIABLE - 4.0MM SELF DRILLING 14MM SCREW WAS NOT MADE AVAILABLE FOR INVESTIGATION AS THE EXPLANT WAS DISCARDED AT THE HOSPITAL AT THE TIME OF THE REVISION SURGERY. FURTHERMORE, NO X-RAYS WERE PROVIDED FOR ANALYSIS. THE DISTRIBUTOR NOTED DURING THE REVISION SURGERY THAT THE LOCKING MECHANISM FEATURE OF THE CERVICAL PLATE PREVIOUSLY IMPLANTED ON (B)(6) 2020 APPEARED TO BE DEPLOYED AND INTACT; THEREFORE, THE REPORTED FAULT DOES NOT INDICATE A MALFUNCTION ASSOCIATED WITH THE LOCKING MECHANISM. THE REVISION SURGERY CONSISTED OF REMOVING THE 81-1614 VARIABLE - 4.0MM SELF DRILLING 14MM SCREW FROM THE 3-LEVEL CONSTRUCT, REPLACING IT WITH QTY (1) 81-1814 VARIABLE - 4.3MM SELF TAPPING 14MM SCREW, AND REDEPLOYING THE LOCKING MECHANISM.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT ANTERIOR CERVICAL FIXATION CONSISTING OF THE CABO ANTERIOR CERVICAL PLATE SYSTEM. SEASPINE WAS INFORMED OF A REVISION SURGERY THAT OCCURRED ON (B)(6) 2020 AS A RESULT OF A POSTOPERATIVE SCREW MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656079 CABO ANTERIOR CERVICAL PLATE SYSTEM VARIABLE -4.0MM SELF DRILLING, 14MM KWQ SEASPINE INC. 81-1614 10889981160913

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention