BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5349986 · Received January 7, 2016

    Report

    Report Number
    1030489-2016-00082
    Event Type
    Injury
    Date Received
    January 7, 2016
    Report Date
    December 24, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PRODUCT WAS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG ID # 70467560 AND 510K# K050439 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR FUSION AND INTERBODY FUSION AT TH10-ILIAC FOR DEGENERATIVE SCOLIOSIS ON (B)(6) 2015. POST-OP, DECUBITUS WAS DEVELOPED DUE TO PROTRUSION OF PLACED SCREW AT ILIAC ON UNKNOWN DATE. REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW AT ILIAC. IT WAS REPORTED THAT THE PLACED SCREW SEEMED TO PROTRUDE RIGHT AFTER THE OPERATION. IT WAS REPORTED THAT THE SCREW WAS NOT TIGHTENED ENOUGH AND THAT COULD BE ONE OF THE CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11072 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention