BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8531049 · Received April 19, 2019

    Report

    Report Number
    1030489-2019-00441
    Event Type
    Injury
    Date Received
    April 19, 2019
    Report Date
    April 19, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICES: THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY. SOME OF THE FOLLOWING PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER THEIR SIMILAR DEVICES HAVE BEEN CLEARED FOR SALE IN THE UNITED STATES. THESE SIMILAR PARTS HAVE BEEN MENTIONED IN THE BRACKETS. PRODUCT ID: 779325555, QTY: 5. (SIMILAR PRODUCT: 779125555, 510(K): K101074, UDI: (B)(4)). PRODUCT ID: G869H021, QTY: 2. (SIMILAR PRODUCT: 869-021, 510(K): K040962, UDI: (B)(4)). PRODUCT ID: 7078396, QTY: 2. (SIMILAR PRODUCT: 5440030, 510(K): K102555, UDI: (B)(4)). PRODUCT ID: 4986045, QTY: 2, 510(K): K133205, UDI: (B)(4). PRODUCT ID: G7753807, QTY: 2, 510(K): K180851, UDI: ASKU. PRODUCT ID: 5530030, QTY: 2. (SIMILAR PRODUCT: 5440030, 510(K): K102555, UDI: (B)(4)). PRODUCT ID: 5531415, QTY: 1, 510(K): K150178, UDI: (B)(4). PRODUCT ID: 55740005530, QTY: 1. (SIMILAR PRODUCT: 55840005530, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740005535, QTY: 2. (SIMILAR PRODUCT: 55840005535, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740006530, QTY: 1. (SIMILAR PRODUCT: 55840006530, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740006535, QTY: 3. (SIMILAR PRODUCT: 55840006535, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740006540, QTY: 2. (SIMILAR PRODUCT: 55840006540, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740006545, QTY: 4. (SIMILAR PRODUCT: 55840006545, 510(K): K113174, 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 THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AND FIXATION AT T6-L3 DUE TO KYPHOSIS. AFTER APPROXIMATELY ONE WEEK POST-OP, PATIENT HAD FEVER. WHEN EVALUATION WAS PERFORMED, INFECTION WAS FOUND. HENCE, A REVISION SURGERY WAS PERFORMED FOR THE REMOVAL OF ALL IMPLANTS ON (B)(6) 2019. NEW IMPLANTS WERE INSERTED DURING THE REVISION SURGERY. NO MALFUNCTION WITH ANY OF THE IMPLANTS WAS ALLEGED WHICH COULD HAVE LED TO INFECTION. THE SEVERITY OF THE INFECTION WAS DETERMINED TO BE NOT SERIOUS. ALLEGEDLY, THE PATIENT HAS STILL NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323905 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention