BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNID ROD

    MDR report key: 19849474 · Received July 29, 2024

    Report

    Report Number
    1000432246-2024-00016
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 27, 2024
    Report Date
    October 5, 2024
    Manufacturer
    MEDICREA INTERNATIONAL SA
    Product Code
    MNI
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPHIC IMAGE REVIEW: ANTERO-POSTERIOR STANDING X-RAY, ROD APPEARS FRACTURED ON ONE SIDE. MAGNIFIED VIEW OF IMAGE SHOWS ONE ROD IS FRACTURED AT MID THORACIC REGION. LATERAL VIEW OF ROD IS FRACTURED AT APEX OF CURVE. LATERAL X-RAY MAGNIFIED ONE OF THE CAP SCREW MAY BE OUT OF TULIP AT BOTTOM THE CONSTRUCT L3. 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.

    Additional Manufacturer Narrative · 0

    G4: PLEASE NOTE THAT THE INVOLVED DEVICE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE WITH PRODUCT FAMILY - UNID ROD, PRODUCT ID B33226012-02, 510K# K140738, UDI# (B)(4). 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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERWENT REVISION SURGERY. PRE-OP DIAGNOSIS OF PATIENT WAS KYPHOSIS. IT WAS REPORTED THAT, THE UNID RODS WERE BROKEN POST-OPERATIVELY. PATIENT HAD A SYMPTOM OF PAIN AS A RESULT OF BROKEN RODS. REVISION SURGERY WAS PERFORMED AND THE BROKEN RODS WERE EXPLANTED. PROCEDURE OR TECHNIQUE PE RFORMED WAS OPEN THORACOLUMBAR FUSION. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375951 UNID ROD ORTHOSIS, SPINAL PEDICLE FIXATION MNI MEDICREA INTERNATIONAL SA B33225522 22D0265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention