BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5115815 · Received October 1, 2015

    Report

    Report Number
    1030489-2015-02540
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Report Date
    September 7, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT POSTERIOR FUSION AT L1-4 LEVELS USING 4.75 FOR OYL AND AT TH7-9 LEVELS USING 5.5-6.0 FOR OPLL. POST-OP, STENOSIS AT L1 LEVEL DUE TO OYL WORSENING WAS OBSERVED. REVISION SURGERY FOR DECOMPRESSION AND FUSION WAS OPERATED TO REPLACE SOLERA 4.75 WITH SOLERA 5.5-6.0 AND CONNECTED WITH LONG RODS BETWEEN THORACIC AND LUMBER LEVELS. DURING SURGERY, IT WAS FOUND THAT SET SCREWS AT L2-4 HAD BEEN DISLODGED. DR COMMENT: THE WEIGHT OF THE PATIENT MAY BE CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647841 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1