BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8006892 · Received October 25, 2018

    Report

    Report Number
    1030489-2018-01405
    Event Type
    Injury
    Date Received
    October 25, 2018
    Report Date
    October 25, 2018
    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

    ADDITIONAL PRODUCT:THIS PRODUCT (PART#55740005540, LOT#H5364923, QUANTITY:02) IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG #55840005540, 510K# K113174 AND UDI (B)(4) IS APPROVED FOR SALE IN US. THIS PRODUCT (QUANTITY: 06) IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG #55840006540, 510K# K113174 AND UDI (B)(4)IS APPROVED FOR SALE IN US. ALTHOUGH IT IS UNKNOWN IF ABOVE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR PSEUDOARTHROSIS AND UNDERWENT POSTERIOR SPINAL FUSION AT T10/11-L1/2. POST-OP, T10 SCREW BACKED OUT AND THIS EVENT HAD IMPACT TO T9 VERTEBRAL BODY AS WELL. PAIN OCCURED AS THE RESULT OF THE EVENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. SCREW ON T10 WAS REMOVED AND BIOPEX WAS INJECTED INTO EMPTY SPACE, HOOK WAS PLACED AT T6/7/8 AND CONNECTED WITH MRC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847682 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5423829

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R