BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYRAMESH® C TITANIUM MESH

    MDR report key: 22083498 · Received May 26, 2025

    Report

    Report Number
    3014725904-2025-00109
    Event Type
    Malfunction
    Date Received
    May 26, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 26, 2025
    Manufacturer
    MEDTRONIC MEDICAL COSTA RICA S.R.L.
    Product Code
    EZX
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3: PLEASE NOTE THAT THIS DEVICE G905H137 (PYRAMESH® C TITANIUM MESH) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE 905-403 (PYRAMESH® C TITANIUM MESH). THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS. SIMILAR DEVICE PRODUCT: 905-403 ; UDI # (B)(4) ; 510(K)# K011406 ; PRODUCT FAMILY: PYRAMESH® C TITANIUM MESH. H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332216 PYRAMESH® C TITANIUM MESH MESH, SURGICAL, METAL EZX MEDTRONIC MEDICAL COSTA RICA S.R.L. G905H137 0068392C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention