BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 5090460 · Received September 21, 2015

    Report

    Report Number
    1030489-2015-02434
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    August 23, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G7540020 / LOT: H5153274 (X2) PART: G7540020 / LOT: H5153275 (X1) PART: G7540020 / LOT: H5153273 (X5) PART: G7540020 / LOT: H5152533 (X1) PART: G7540020 / LOT: H5130321 (X1) PART: G7540020 / LOT: H5116024 (X4) PART: G75444530 / LOT: H11D0456 (X1) PART: G75444530 / LOT: H11C2594 (X1) PART: G75444530 / LOT: H10H0866 (X1) PART: G75444530 / LOT: H10G3041 (X1) PART: G75444535 / LOT:H10K1414 (X1) PART:G75444535 / LOT:H10G3594 (X1) PART: G75444535/LOT: H11A7117 (X1) PART:G75444535/ LOT: H10B3448 (X1) PART:G75444535/ LOT: H11E0980 (X1) PART: G811H306 / LOT: 0384414W (X1) PART: G811H307 / LOT: 0367310W (X1) PART: G869H021 / LOT: 0389525W (X1) ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    LEVELS IMPLANTED (LI): TH5-TH9 DETAILS OF LEVELS IMPLANTED: INITIAL SURGERY CONDUCTED ON (B)(6) 2010. LEVEL OF FIXATION EXTENDED OVER UPPER VERTEBRAE AND ROD REMOVED TO REDO FIXATION IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT POSTERIOR FUSION AT TH5-TH9 LEVELS TO TREAT OPLL/PLF .ON (B)(6) 2015, SURGEON EXTENDED THE LEVELS OF THE FIXATION. DURING HIS FOLLOW-UP PERIOD POST-OP, THE PATIENT TRIED SITTING ON THE BED AND NUMBNESS DEVELOPED AND SOON PROGRESSED. THE PATIENT UNDERWENT DECOMPRESSION REVISION SURGERY ON (B)(6) 2015. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. AS PER SURGEON, NUMBNESS WORSENED PROBABLY BECAUSE OSSIFICATED LONGITUDINAL LIGAMENT GOT COMPRESSED BY SPINAL MISALIGNMENT CAUSED BY SITTING POSITION. SR'S COMMENT: THE SURGEON SUSPECTS THE WORSENING OF NUMBNESS IS NOT RESULTED FROM THE IMPLANT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622610 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Other