BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX (R) INTERLAMINAR TECHNOLOGY

    MDR report key: 4120859 · Received September 23, 2014

    Report

    Report Number
    3005725110-2014-00004
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    November 4, 2013
    Report Date
    September 22, 2014
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COFLEX REMOVAL SURGERY TO RELIEVE PERSISTENT INCREASED PAIN AFTER TRAUMA: PT RECEIVED A COFLEX IN L4-L5 ON (B)(6) 2010. PT WAS DOING WELL UNTIL SHE SAT ON A FOLDING CHAIR THAT COLLAPSED ON (B)(6) 2013. SHE THEN HAD ONGOING BACK PAIN AND RADIATING LEG PAIN. SHE DESCRIBED BURNING PAIN IN HER BUTTOCKS BILATERALLY WITH STABBING ON THE RIGHT SIDE, PINS AND NEEDLES SENSATIONS DOWN HER LEGS BILATERALLY BOTH ANTERIORLY AND POSTERIORLY AND SOME STABBING IN HER LEFT FOOT AS WELL. DIAGNOSIS: POST TRAUMA LUMBAR INSTABILITY, LATERAL RECES FORAMINAL STENOSIS, PROGRESSIVE RADICULOPATHY. SHE THEN HAD A REVISION SURGERY: REMOVAL OF COFLEX IMPLANT FOLLOWED BY COMPLETE LAMINECTOMY, FACETECTOMY, FORAMINOTOMY, REDO DECOMPRESSION WITH NONSEGMENTAL PEDICLE SCREW FIXATION INTO L4-L5 INTERBODY FUSION WITH EXPANDABLE CAGES, SPONDYLO REDUCTION, POSTEROLATERAL BILATERAL FUSION WITH LOCALLY HARVESTED MORSELIZED BONE, FROZEN ALLOGRAFT, INTERBODY FUSION, NONSEGMENTAL FIXATION, COMPLETE DECOMPRESSION OF THE SPINAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591203 COFLEX (R) INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPAC NQO PARADIGM SPINE GMBH UAI00010 2006000708

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention