BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3193053 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02591
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    January 19, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE: PART G7540120, LOT # 0228970W; PART G7540120, LOT # 0232238W; PART G7540120, LOT # 0232271W; PART G7540120, LOT # 0232749W; PART G75496545, LOT # 0152690W; PART G75496545, LOT # 0162835W; PART G75496545, LOT # 0188778W; PART G75496545, LOT # 0191502W; PART G75496545, LOT # 0193916W; PART G75497540, LOT # 0123751W; PART G75497540, LOT # 0165829W; PART G8699100, LOT # 0040264W; PART G8699100, LOT # 0044404W; PART 4200822INT, LOT # H12F1371; PART 4200822INT, LOT # H12J2861; 4200822INT, LOT # VP49. (B)(6). (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR SPINAL SURGICAL PROCEDURE TO TREAT LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292710 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention RODS, SCREWS, VB REPLACEMENT