BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX

    MDR report key: 17525415 · Received August 12, 2023

    Report

    Report Number
    MW5132356
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    November 24, 2016
    Manufacturer
    COFLEX
    Product Code
    NQO
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEY HAD SPINAL SURGERY IN (B)(6) 2016 AND USED A COFLEX DEVICE. FOR THE FIRST 5 DAYS THEY WERE FINE, HOWEVER, ON DAY 6 THEY DEVELOPED A FEVER, WERE NOT FEELING WELL, AND THEIR PAIN STARTED RETURNING. THE PATIENT ALSO REPORTED THAT AT THEIR POST-OP APPOINTMENT AROUND MEMORIAL DAY, THEIR PAIN WAS 100 TIMES WORSE THAN PRIOR TO THE SURGERY AND THAT THERE WAS PUS COMING OUT OF THE SURGICAL SITE AND THAT IT WAS INFECTED. THE PATIENT STATED THAT 41-66 CC FLUID WAS DRAINED FROM THE SITE AND THEY WERE GIVEN A PRESCRIPTION FOR PHYSICAL THERAPY. ON (B)(6)13, THE PATIENT HAS EMERGENCY SURGERY AND THE SITE WAS CLEANED OUT AND THEY WERE GIVEN ANTIBIOTICS. 601497394. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563985 COFLEX PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO COFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown