BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 20207337 · Received September 12, 2024

    Report

    Report Number
    3005031160-2024-00031
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    June 29, 2015
    Report Date
    September 12, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS NOTIFIED OF THIS COMPLAINT ON AUGUST 16, 2024. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE COMPLAINANT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING RECORDS WAS UNABLE TO BE PERFORMED AS THE PART AND LOT INFORMATION FOR THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. NO FURTHER INVESTIGATION WAS ABLE TO BE COMPLETED AT THS TIME. THE IFU FOR THE COFLEX SYSTEM WARNS "RISKS ASSOCIATED WITH DECOMPRESSIVE PROCEDURES AND POSTEROLATERAL FUSION FOR TREATMENT OF SPINAL STENOSIS AND INSTABILITY INCLUDE: DAMAGE TO NERVES LEADING TO SENSORY OR MOTOR DEFICITS; PARALYSIS; PARASTHESIA; CAUDA EQUINA SYNDROME; DAMAGE TO NERVES, BLOOD VESSELS, AND NEARBY TISSUES" ADDITIONALLY, THE IFU WARNS "THERE IS ALSO THE RISK THAT SURGERY MAY NOT BE EFFECTIVE IN RELIEVING SYMPTOMS, OR MAY CAUSE WORSENING OF SYMPTOMS. ADDITIONAL SURGERY MAY BE REQUIRED TO CORRECT SOME OF THE ADVERSE EFFECTS." IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTERLAMINAR STABILIZATION SURGERY INVOLVING A COFLEX IMPLANT. THIS INITIAL SURGERY WAS DONE IN (B)(6) 2015 AND IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF CAUDA EQUINA SYNDROME. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2015 TO REMOVE THIS COFLEX IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592455 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO XTANT MEDICAL HOLDINGS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown Required Intervention