BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSEM

    MDR report key: 1822668 · Received August 27, 2010

    Report

    Report Number
    1030489-2010-01100
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    May 11, 2007
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MANUFACTURING
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WITHOUT ADDITIONAL DEVICE INFO, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE. WE ARE THEREFORE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIME AFTER THE PT UNDERWENT A POSTERIOR DECOMPRESSION AND FUSION, LUMBAR INTERBODY FUSION FROM L3 TO S1 AND ROD PLACEMENT FROM L2 TO L3, HE FELT A "TWANG" IN HIS BACK. HE WAS REPORTEDLY EXPERIENCING INTENSE BACK PAIN SINCE THAT TIME. A CT SCAN WAS PERFORMED BUT SHOWED NO CLEAR EVIDENCE OF A DEVICE FAILURE. AT THIS TIME THERE APPEARS TO BE NO PLAN FOR SURGICAL EXPLORATION OR DEVICE REMOVAL AND IT IS NOTED THAT THE PT WOULD LIKE TO BE ABLE TO CONTROL WITH PAIN MANAGEMENT. NO OTHER DETAILS ARE CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSEM NQP MEDTRONIC SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other