BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 6185169 · Received December 19, 2016

    Report

    Report Number
    3005725110-2016-00006
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    September 16, 2016
    Report Date
    December 19, 2016
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    UDI-DI
    04260148898525
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED PER MDR (B)(4): "THE PATIENT ORIGINALLY UNDERWENT A SURGERY FOR L3 4 L4 5 DECOMPRESSIVE LAMINECTOMY FOR LUMBAR SPINAL STENOSIS WITH POSTERIOR STABILIZATION USING THE COFLEX INTERSPINOUS PROCESS CLAMP ON (B)(6) 2016. NO COMPLICATIONS WERE REPORTED DURING THE ORIGINAL PROCEDURE. THE PATIENT DID RETURN FOR HOSPITALIZATION ON (B)(6) 2016 FOR DEVELOPMENT OF DRAINAGE FROM THE INCISION SITE THAT DID NOT SUBSIDE. ON (B)(6) 2016 THE PATIENT AGAIN RETURNED TO THE HOSPITAL FOR A SURGICAL PROCEDURE RELATED TO LOOSE ORTHOPEDIC IMPLANT AND REMOVAL OF THE POSTERIOR SPINAL INSTRUMENTATION. THE NEUROSURGEON DOCUMENTED THAT THE PATIENT RECENTLY WAS SEEN FOR WITH COMPLAINTS OF INCREASING LOWER BACK PAIN ASSOCIATED WITH MOVEMENT. THE DOCUMENTATION REVEALED THAT IT WAS SOMEWHAT MORE ON THE LEFT SIDE THAN THE RIGHT AND X-RAYS WERE OBTAINED THAT SHOWED THE COFLEX DEVICE HAD MIGRATED POSTERIORLY AND WAS NO LONGER IN THE INTERSPINOUS SPACE. REMOVAL WAS DONE IN HOPES OF HELPING THE PATIENT WITH HIS RESIDUAL BACK PAIN. THE NEUROSURGEON DOCUMENTED THAT FLEXION EXTENSION X-RAYS FAILED TO SHOW ANY OBVIOUS INSTABILITY. POST-OPERATIVE MRI SCAN SHOWED SUCCESSFUL DECOMPRESSION OF THE SPINAL CANAL. NO FURTHER INFORMATION WAS AVAILABLE AND NO SPECIFIC DOCUMENTATION WAS FOUND THAT THE DEVICES HAD SPECIFIC CONCERNS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838288 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO PARADIGM SPINE GMBH UQI00012 2014003575 04260148898525

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization