BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM OPEN CONNECTOR CLOSURE TOP

    MDR report key: 5258685 · Received December 1, 2015

    Report

    Report Number
    2184052-2015-00126
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    October 30, 2015
    Report Date
    November 2, 2015
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE REPORTED UPON FURTHER EVALUATION OF THE EVENT DETAILS.

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2015-00127 AND 2184052-2015-00128. IT WAS REPORTED THAT A REVISION SURGERY OCCURRED DUE TO POSTOPERATIVE LOOSENING OF THREE NEXLINK CLOSURE TOPS. THE PATIENT WAS INITIALLY IMPLANTED WITH NEXLINK AT T5-T6-T7 FOR THE TREATMENT OF EDH (EHLERS-DANLOS SYNDROME). APPROXIMATELY SIX (6) MONTHS LATER, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THREE LOOSE CLOSURE TOPS ON THE LEFT SIDE OF THE CONSTRUCT ALLOWING FOR THE ROD TO COME LOOSE. PARTIAL FUSION WAS REPORTED TO HAVE BEEN SEEN AT THE TIME OF THE REVISION SURGERY. THE PATIENT WAS RE-IMPLANTED WITH NEW A NEXLINK ROD AND LOCKING CAPS DURING THE REVISION TO REPLACE THE THREE CLOSURE TOPS AND ROD THAT HAD LOOSENED POSTOPERATIVELY. NO PATIENT CONDITIONS HAVE BEEN REPORTED FOLLOWING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788036 4.0MM OPEN CONNECTOR CLOSURE TOP 4.0MM OPEN CONNECTOR CLOSURE TOP KWP 707-01

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR