BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2049049 · Received April 11, 2011

    Report

    Report Number
    1030489-2011-00398
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    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)(4). THE DEVICES THAT WERE USED ARE PART# 54740006540, LOT H10L0105, EXPIRATION DATE 11/20/2018; PART #7068396, LOT H10M2095, EXPIRATION DATE 12/14/2018. THESE TWO PARTS ARE BOTH NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE 510K # K042025 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H10L0105 IS 11/20/2010; THE MANUFACTURE DATE FOR LOT H10M2095 IS 12/20/2010. DEVICE HISTORY RECORDS AND A REVIEW OF THE STERILIZATION CERTIFICATE ARE UNDER REQUESTING. THE FOLLOW UP REPORT WILL BE REPORTED WHEN WE RECEIVE THE INFORMATION. PER THE REPORTER, THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE. HOWEVER, IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS AND STERILIZATION CERTIFICATION FOR REPORTED DEVICES ARE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLF TO IMPLANT THE POSTERIOR FIXATION AT T11/L1. REPORTEDLY, THE PATIENT HAD A FEVER AND WAS SUSPECTED TO HAVE AN INFECTION POST OP. THE REMOVAL SURGERY WAS PERFORMED APPROXIMATELY A MONTH POST OP. REPORTEDLY, THE INFECTION IS NOT BELIEVED TO BE RELATED TO THE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention ROD, PEDICLE SCREWS, AND SET SCREWS