BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC IMPLANT

    MDR report key: 2313362 · Received October 28, 2011

    Report

    Report Number
    1030489-2011-01398
    Event Type
    Injury
    Date Received
    October 28, 2011
    Report Date
    September 29, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PICHELMANN ET AL IN A PUBLICATION ENTITLED "REVISION RATES FOLLOWING PRIMARY ADULT SPINAL DEFORMITY SURGERY: SIX HUNDRED FORTY-THREE CONSECUTIVE PATIENTS FOLLOWED-UP TO TWENTY-TWO YEARS POSTOPERATIVE" (THE SPINE JOURNAL 35 (2010) 219-226) THAT 58 PATIENTS (9.0%) REQUIRED AT LEAST 1 REVISION. FIFTEEN OF 643 (2.3%) REQUIRED MORE THAN 1 PROCEDURE. THE MEAN TIME TO REVISION WAS 4.0 YEARS. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED NEUROLOGIC DEFICIT WHICH RESULTED IN AN UNANTICIPATED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MEDTRONIC IMPLANT N/A MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention