BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 12237302 · Received July 28, 2021

    Report

    Report Number
    1030489-2021-00986
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Report Date
    July 28, 2021
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE WITH CATALOG # 55811015540, UPN# 00643169065314 AND 510K # K122433 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 FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR T9 COLLAPSE AND SCREW LOOSENESS. LEVEL IMPLANTED T10-L5. IT WAS REPORTED THAT THE REMOVAL WAS PERFORMED AT T9 FOR LOOSENING OF SCREWS. L2 SCREWS WERE REPLACED. ADDITIONAL CONNECTION EXTENSION OF L3, 4 AND 5 WAS PERFORMED. THERE WAS HEALTH DAMAGE TO THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WAS NO MALFUNCTION ASSOCIATED WITH THE EVENT. IT BECAME A REOPERATION BECAUSE IT BECAME DIFFICULT FOR PATIENT TO WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133219 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG 55740017540 H5606323

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention