BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CMF DURHAM_PRODUCT

    MDR report key: 21621811 · Received March 17, 2025

    Report

    Report Number
    3005920920-2025-00002
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    December 23, 2024
    Report Date
    June 5, 2025
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC
    Product Code
    NQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. THE REPORTED OBSERVATION COULD NOT BE CONFIRMED, AND THE ADHERUS DEVICE WAS DISCARDED AFTER SURGERY, PREVENTING FURTHER TESTING OR BATCH REVIEW DUE TO LACK OF LOT INFORMATION. ALTHOUGH THE SURGEON WAS TRAINED AND USED THE DEVICE CORRECTLY, NO ROOT CAUSE FOR THE EVENT COULD BE DETERMINED BASED ON THE AVAILABLE INFORMATION. BASED ON THE INVESTIGATION INCLUDING STATISTICAL ANALYSIS, THERE IS NO INDICATION FOR AN INCORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL, OR MANUFACTURING-RELATED ISSUE. THEREFORE, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CSF LEAK AFTER SURGERY.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17623 UNKNOWN_CMF DURHAM_PRODUCT IMPLANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other