BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 7040040 · Received November 17, 2017

    Report

    Report Number
    3005725110-2017-00007
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    September 1, 2016
    Report Date
    January 10, 2018
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT NOT SATISFIED WITH DEVICE REMOVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE PATIENT UNDERWENT A LAMINECTOMY AND COFLEX AT L4-5. SHE CONTINUED TO EXPERIENCE CHRONIC BACK PAIN. HER SURGEON SENT HER TO PHYSICAL THERAPY. HER TREATING SURGEON MOVED AWAY TO ACCEPT A NEW POSITION. HER CARE WAS TRANSFERRED TO A PARTNER. FOLLOW-UP MRI SCAN AND CT SCAN WERE OBTAINED AND EVENTUALLY SHE UNDERWENT REMOVAL OF THE COFLEX AND HAD A FUSION L3-S1 (B)(6) 2016. THIS WAS COMPLICATED WITH HIGH BLOOD LOSS AND A DEEP VEIN THROMBOSIS. SHE CONTINUES TO HAVE CHRONIC LUMBAR PAIN. SHE HAS NOT RETURNED TO WORK, AND DOES NOT PLAN TO RETURN TO WORK. POST FUSION MRI AND CT SCANS WERE OBTAINED. HER REPORT INDICATES "FRACTURES OF L4 AND L5" AND SOME LOOSENING OF HER SCREWS. SHE HAS THE COFLEX DEVICE AND IT IS IN SEVERAL PIECES FROM THE REMOVAL PROCESS. SHE STATED THAT THE COFLEX SURGERY WAS EASY COMPARED TO THE FUSION AND THAT SHE WOULD TRY IT AGAIN IF SHE COULD DO IT ALL OVER AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822129 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO PARADIGM SPINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention