BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA 5.5/6.0

    MDR report key: 10464094 · Received August 28, 2020

    Report

    Report Number
    1030489-2020-01164
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    August 28, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1606200500, 510K # K131321; UDI#(B)(4) WAS CLEARED IN THE UNITED STATES. 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 A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A ROD UNDERGOING THE REPLACEMENT OF THE BROKEN ROD. IT WAS REPORTED THAT THE INITIAL SURGERY OF POSTERIOR FIXATION (T10-IL)L2/3PLIF L5/SPLIF OCCURED ON (B)(6) 2018. THE ROD BROKE ON AN UNKNOWN DATE AND IT IS PLANNED TO PERFORM A REVISION SURGERY FOR REPLACING THE BROKEN ROD ON (B)(6) 2020. THE PATIENT EXPERIENCED LOWER BACK PAIN. IN THE DOCTOR'S OPINION, THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE USE OF MEDTRONIC PRODUCTS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928320 CD HORIZON SOLERA 5.5/6.0 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1604300500 0558076W

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R