BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8973979 · Received September 9, 2019

    Report

    Report Number
    1030489-2019-00996
    Event Type
    Injury
    Date Received
    September 9, 2019
    Report Date
    September 9, 2019
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440130, 510K # K102555 AND UPI: (B)(4) 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY. DURING THE SURGERY, DOUBLE RODS WERE PLACED AT THE LEFT SIDE OF L5 AND ILIAC USING PEDICLE SCREW. ON THE RIGHT SIDE, HOOK WAS PLACED AT L4-S1 AND SCREW FIXATION WAS PERFORMED AT ILIAC. ON UNKNOWN DATE, POST-OP, SET SCREW ON THE LEFT SIDE OF ILIAC DEVIATED AND THERE WAS SURGICAL SITE INFECTION. NO FUSION WAS ACHIEVED. THE PATIENT ALSO EXPERIENCED A LEFT LOWER EXTREMITY PAIN. HENCE, A REVISION SURGERY WAS PERFORMED TO RE-FIX THE DEVIATED SET SCREW. NO INFORMATION OF PATIENT OUTCOME IS AVAILABLE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771182 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention