BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA 5.5/6.0

    MDR report key: 10533982 · Received September 15, 2020

    Report

    Report Number
    1030489-2020-01287
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 15, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIMILAR DEVICE WITH PRODUCT ID: 55840014530 AND 510(K)#: K113174 IS MARKETED IN US. 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 PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR PYO GENIC SPONDYLITIS AT T7/8. IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR FUSION EXTENSION WHICH BECAME NECESSARY DUE TO PYOGENIC SPONDYLITIS AND REPLACEMENT OF BACKED OUT SCREWS. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-AUG-25: THE PRODUCTS WERE EXPLANTED AND WILL NOT BE RETURNED AS THEY WERE DISCARDED BY CUSTOMER. ADDITIONAL INFORMATION WAS RECEIVED ON 2020-SEP-08: THE EVENT HAPPENED ONE YEAR AFTER THE INITIAL OPERATION THAT HAPPENED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998916 CD HORIZON SOLERA 5.5/6.0 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG 55790014530 H5339149

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention