BEUDAMED
    FDA Adverse Event Summary report: N

    COFLEX(R) INTERLAMINAR TECHNOLOGY

    MDR report key: 4188663 · Received October 17, 2014

    Report

    Report Number
    3005725110-2014-00006
    Date Received
    October 17, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 16, 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

    Additional Manufacturer Narrative · 1

    IMPLANTS WERE USED OFF LABEL USED WITH FUSION AND AT L5-S1. COFLEX IS NOT INTENDED TO BE USED AS SUPPLEMENT TO FUSION. COFLEX IS NOT INTENDED TO BE USED IN L5-S1. TEN DAYS POST OP THE PT HAD REMOVAL OF IMPLANTS AND EXTENSION OF THE FUSION WITH COMPLETE LAMINECTOMY AND TLIF L3 TO S1. THE PTS APPEARS TO HAVE HAD A POST OP CAUDA EQUINA SYNDROME OR EPIDURAL HEMATOMA AS THE PT PRESENTED WITH LOSS OF BLADDER CONTROL. THESE ARE TECHNIQUE RELATED COMPLICATIONS ASSOCIATED WITH OFF LABEL USE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE PT UNDERWENT A BILATERAL HEMILAMINOTOMY, FACETECTOMY, FORAMINOTOMY AT L4-5, L5-S1. SPINAL REDUCTION AT L4-5. POSTEROLATERAL FUSION WITH LOCALLY HARVESTED MORSELIZED BONE AND FROZEN ALLOGRAFT PLUS INSERTION OF TWO COFLEX INTERLAMINAR IMPLANTS AT L4-5, L5-S1. ON (B)(6) 2014 SHE WAS READMITTED WITH LOSS OF BLADDER CONTROL. A SEMI EMERGENT DECOMPRESSION AND PEDICLE SCREW STABILIZATION WAS PERFORMED: REMOVAL OF COFLEX IMPLANTS WITH LAMINECTOMY, FACETECTOMY, FORAMINOTOMY AT L3-4, L4-5, AND L5-S1, PEDICLE SCREW STABILIZATION L3-S1, TLIF FUSION AT L3-4, L4-5 WITH SPONDYLOREDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660016 COFLEX(R) INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE GMBH UQI00010, UQI00014 2013004556, 2013005

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention