BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 3276861 · Received August 9, 2013

    Report

    Report Number
    1030489-2013-03457
    Event Type
    Injury
    Date Received
    August 9, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    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. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 76446540, PART: 7540020, PART: 9690030, PART: 9193011, LOT: LV25, PART: 7510400, LOT: M115997AA. ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2006, PATIENT UNDERWENT A POSTERIOR SPINAL FUSION L5 TO S1 WITH TLIF AT L5-S1 TO TREAT DEGENERATIVE LUMBAR DISEASE AT L5-S1, BILATERAL RADICULOPATHY AND BILATERAL SACROLITIS. NO INTRA-OP PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT PRESENTS TO THE ER 7 DAYS POST-OP WITH LOW BACK PAIN. APPROXIMATELY 1.5 YEARS POST-OP THE PATIENT UNDERWENT ¿REMOVAL OF HARDWARE, LUMBAR SPINE L5-S1 I.E., PEDICLE SCREWS AND RODS, EXPLORATION OF FUSION, L5-S1, AND DECOMPRESSION/HEMI LAMINECTOMY FAR LATERAL NERVE ROOT DECOMPRESSIONS OF L5 NERVE ROOT¿ TO TREAT LOWER BACK PAIN/LEFT LEG RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378093 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PEDICLE SCREWS, RODS, BMP2