BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON LEGACY

    MDR report key: 2980915 · Received December 21, 2012

    Report

    Report Number
    2980915
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 11, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FEMALE WHO HAD A POSTERIOR SPINAL FUSION L4-S1 FOR SPONDYLOLISTHESIS IN (B)(6) 2010. IN (B)(6) 2012,PATIENT BEGAN HEARING A NOISE WHEN SHE MOVED AND BEGAN HAVING PAIN OVER PAST 4-6 WEEKS LIKE SHE HAD BEFORE SURGERY. X-RAYS REVEALED BROKEN RODS BETWEEN L5 AND S1. PATIENT AND FAMILY OPTED TO HAVE REVISION SURGERY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?POSTERIOR SPINAL FUSION FROM L4-S1 WITH 5.5 MEDTRONIC STAINLESS STEEL IMPLANTSDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON LEGACY RODS (2) HSB MEDTRONIC SOFAMOR DANEK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other| R MEDTRONIC PEDICLE SCREWS (2)- (B)(4)/(1) (B)(4)| ANULES (L) 30CC--,(L) 30CC -| 0 (2) (B)(4) (2) (B)(4) (L) (B)(4)- SET SCRE| WS (8): CATALOGUE #7540020, CORTICAL CANCELLOUS GR