BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® FENESTRATED SCREW SET

    MDR report key: 13469666 · Received February 7, 2022

    Report

    Report Number
    1030489-2022-00102
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    December 20, 2021
    Report Date
    February 7, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KIH
    UDI-DI
    20763000211039
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CEMENT IN AN AUGMENTATION PROCEDURE. IT WAS REPORTED THAT THE CEMENT LEAKED INTO SCREW TULIP DUE TO CEMENTATION WITH VOYAGER SCREWS. SCREWS HAVE BEEN USED WITH AUGMENTATION PROCEDURE BUT THE CEMENT LEAKED OUT BETWEEN SCREW CRONE AND VOYAGER DISPOSABLE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS A DELAY OF 30 MINUTES IN THE SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595314 CD HORIZON® FENESTRATED SCREW SET DISPENSER, CEMENT KIH WARSAW ORTHOPEDICS 6550202 UNKNOWN 20763000211039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown