BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    MDR report key: 8062093 · Received November 12, 2018

    Report

    Report Number
    1030489-2018-01470
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    February 15, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    UDI-DI
    00643169501133
    PMA / PMN Number
    K143375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 ADDITIONAL PRODUCTS WERE USED IN THE SURGERY. NO. , PRODUCT , LOT , UPN , 510K , QTY- 10, 54750017540 , H5356296 ,(B)(4) K143375 , 1 .20 , 54750017545 , H5352987 , (B)(4)K143375 , 2. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: A MICROSCOPIC REVIEW OF THE BONE SCREW SHOW HEAVY WITNESS MARKS ON ONE SIDE AND LITTLE TO NO WITNESS MARKS ON THE OTHER SIDE. THERE IS AN INDICATION THAT THE ROD WAS ANGULATED IN THE BONE SCREW HEAD. THERE ARE FAINT WITNESS MARKS OF THE ROD ON INSTALLATION BUT NO SIGNS OF FAILURE. THE RODS BEING ANGULATED IN THE HEAD OF THE BONE SCREW COULD LEAD TO THE SCREW BACKING OUT OVER TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: MINIMALLY INVASIVE SPINAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PRE-OPERATIVE DIAGNOSIS: NEUROLOGICAL SYMPTOM IT WAS REPORTED THAT POST-OP, SCREW WAS LOOSE. REVISION SURGERY WAS PERFORMED DUE TO SCREW LOOSING. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901292 CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H5356296 00643169501133

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention