BEUDAMED
    FDA Adverse Event Summary report: N

    COFLEX (R) INTERLAMINAR TECHNOLOGY

    MDR report key: 3809678 · Received April 25, 2014

    Report

    Report Number
    3005725110-2014-00002
    Date Received
    April 25, 2014
    Date of Event
    January 4, 2013
    Report Date
    April 24, 2014
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ABOUT A PT WHO IS PART OF THE PMA CLINICAL TRIALS. ON (B)(6) 2014, AN PARADIGM SPINE EMPLOYEE RECEIVED A FAX REPORTING ABOUT THIS REVISION SURGERY. THIS PERSON WAS NOT AWARE OF THE FACT THAT ADVERSE EVENTS IN COURSE OF THE CLINICAL TRIAL HAVE TO BE REPORTED TO THE FDA VIA A MDR. THE PERSON THOUGHT THIS CASE WAS COVERED BY THE POST-APPROVAL STUDY REPORT INCLUDED IN THE ANNUAL REPORT. SO THIS CASE WAS NOT IMMEDIATELY FORWARDED TO THE QUALITY MANAGEMENT DEPARTMENT WHICH IS RESPONSIBLE FOR MDR REPORTING. THE QUALITY DEPARTMENT WAS FINALLY INFORMED ON 03/28/2014 AND IMMEDIATELY DETERMINED THIS EVENT AS REPORTABLE EVENT AND INITIATED ALL STEPS FOR SUBMITTING THIS REPORT. THE PERSON WAS NOTIFIED THAT ALL IMPLANT RELATED EVENTS HAVE TO BE REPORTED VIA MDR TO THE FDA.

    Description of Event or Problem · 1

    COFLEX REMOVAL DUE TO ONGOING/INCREASING BACK PAIN: SITE CALLED SUBJECT TO SCHEDULE HER 60 MONTH STUDY VISIT AND WAS INFORMED BY THE PT THAT THE DEVICE WAS REMOVED ON (B)(6) 2013 BY DR (B)(6). DR (B)(6) WAS NOT AWARE OF THE DEVICE BEING REMOVED FROM THE PT AND THE DEVICE WASN'T RETURNED TO PARADIGM SPINE. ACCORDING TO SUBJECT'S CHART, SHE HAD BEEN IN FOR HER 48 MONTH STUDY VISIT ON (B)(6) 2012 AND REPORTED BACK PAIN TO DR (B)(6) WHICH HAS BEEN ONGOING. ON (B)(6) 2012, THE SUBJECT WAS SEEN BY DR (B)(6) FOR INCREASED BACK PAIN. DR (B)(6) WAS OUT OF THE OFFICE AT A CONFERENCE. DR (B)(6) ORDERED A MYELOGRAM/CT ON THE PT. THE PT RETURNED ON (B)(6) 2012 FOR HER RESULTS AND WAS THEN REFERRED TO DR (B)(6) ANOTHER SURGEON IN THE PRACTICE. THE SUBJECT WAS SEEN BY DR (B)(6) ON (B)(6) 2012 AND WAS INFORMED SHE NEEDED ADDITIONAL SURGERY. DR (B)(6) WAS NOT PRESENT ON THIS CONVERSATION OR ANY OF THE ABOVE-MENTIONED VISITS. ON (B)(6) 2013, THE SUBJECT HAD T10 TO SACRUM POSTERIOR SPINAL FUSION WITH SEGMENTAL INSTRUMENTATION BILATERAL PELVIC FIXATION, T10 AND T11 VERTEBROPLASTIES, L 1-2 LAMINECTOMY, L5 -S1 ANTERIOR LUMBAR INTERBODY FUSION, ANTERIOR INSTRUMENTATION L5-S1, AND REMOVAL OF SEGMENTAL FIXATION, L3-4 AND L4-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250808 COFLEX (R) INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPAC NQO PARADIGM SPINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention