BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7327794 · Received March 9, 2018

    Report

    Report Number
    1030489-2018-00364
    Event Type
    Injury
    Date Received
    March 9, 2018
    Report Date
    March 9, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    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 US, HOWEVER A LIKE DEVICE WITH PART# 55811015550, 510K# K122433, AND (B)(4) IS APPROVED FOR MARKET IN THE US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. X-RAY REVIEW- L1 BURST FRACTURE TREATED WITH SINGLE LEVEL ABOVE AND BELOW CONSTRUCT. 5.5 MM SCREW AT T 12, 6.5 MM SCREW AT L1 . A SCREW FRACTURE IS SEEN ON POST -OP, X RAY. "TIME FROM IMPLANT IS UNKNOWN. IT IS UNKNOWN IF GRAFT ANGULATION WAS USED. A HARDWARE FRACTURE AT THIS MOBILE LEVEL IS COMMON IF BONY FUSION DOES NOT OCCUR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE : BONE ADHESION AFTER BURST. TYPE AND LEVEL OF INITIAL SURGERY PROCEDURE OR TECHNIQUE USED: 1-1 FUSION WAS PERFORMED FOR L1 BURST. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2017. POST-OP, THE SCREW HEAD'S BASE ON THE RIGHT SIDE OF T12 WAS BROKEN. FOR REMOVING THE BROKEN SCREW, AN ADDITIONAL OPERATION USING PSE1 WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169699 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA16D120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention