BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9827828 · Received March 13, 2020

    Report

    Report Number
    1030489-2020-00302
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    October 10, 2019
    Report Date
    March 12, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 1475501030, 510K: K113174, UDI: (B)(4). PRODUCT ID: 9392513, 510K: K094025, UDI: (B)(4). PRODUCT ID: 54840006540, 510K: K091974, UDI: (B)(4). PRODUCT ID: 5440030, 510K: K102555, UDI: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S SIBLING THAT HIS/HER SISTER HAS AN ALLERGY TO NICKEL. 10 YEARS AGO SHE (THE PATIENT) BROKE HER ARM. SHE HAD TO HAVE A ROD INSERTED WITH METAL SCREWS. HER ARM BECAME INFECTED. METAL SCREWS HAD TO BE REMOVED AND REPLACED WITH PLASTIC SCREWS. ON (B)(6) 2019 SHE HAD SPINAL SURGERY (FUSION SPINE POSTERIOR). SHE WAS HOSPITALIZED FOR OVER 3 MONTHS. HER INCISION GOT INFECTED AND SHE HAD NUMEROUS ANTIBIOTICS. TODAY SHE IS IN VERY CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291597 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R