BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8821460 · Received July 24, 2019

    Report

    Report Number
    1030489-2019-00813
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    April 3, 2019
    Report Date
    August 17, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    X-RAY RESULTS RECEIVED: L2-ILIAC FUSION POST-OP X-RAYS WERE PROVIDED. THERE IS A ROD FRACTURE AT LEFT L5-S1. THE RODS HAVE AN INTERESTING CONTOUR AT THE LUMBOSACRAL TRANSITION. NO LATERAL FILM IS AVAILABLE FOR REVIEW. THERE DOES NOT APPEAR TO BE MUCH OF A LATERAL FUSION MASS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEGENERATIVE SCOLIOSIS OF THE LUMBAR SPINE; MULTILEVEL STENOSIS MOST SEVERE AT THE L4-L5 LEVEL BUT ADDITIONALLY AT L2-L3 AND L3-L4; UP-DOWN STENOSIS WITH FORAMINAL NARROWING BILATERALLY, SEVERE AT THE L5-S1 LEVEL. THE SURGEON PROPOSED A MULTILEVEL DECOMPRESSION AND STABILIZATION DUE TO THE INSTABILITY AND SEVERE ARTHRITIC CHANGES IN THE MID TO LOWER LUMBAR SPINE. SHE UNDERWENT A SURGERY USING THE REPORTED ROD AND AUTOLOGOUS ILIAC CREST BONE GRAFT WITH DEMINERALIZED BONE MATRIX. ON AN UNKNOWN DATE, POST-OP, PATIENT EXPERIENCED PAIN AND BONE GRINDING ON HER LEFT LOWER BACK. ON (B)(6) 2019, IT WAS CONFIRMED BY X-RAY THAT THE ROD HAD FRACTURED AT L5-S1. HER PHYSICIAN IS RECOMMENDING AN ADDITIONAL SURGERY TO REMOVE THE RODS ON BOTH SIDE AND REPLACE THEM, IN ADDITION TO ANTERIOR/POSTERIOR BONE GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616012 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention