BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY

    MDR report key: 21500919 · Received March 2, 2025

    Report

    Report Number
    1030489-2025-01064
    Event Type
    Malfunction
    Date Received
    March 2, 2025
    Date of Event
    March 5, 2024
    Report Date
    March 2, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 3606195 ; LOT # K23E1056 VISUAL AND OPTICAL INSPECTION CONFIRMED THE PIN AT THE TIP OF THE DRIVER HAS BEEN BEND DUE TO BEND STRESS OVERLOAD. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 HAVING SPINAL THERAPY FOR UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT, THE INSTRUMENTS WERE BROKEN. PROCEDURE OR TECHNIQUE PERFORMED WAS ANTERIOR LUMBAR INTERBODY FUSION AND POSTERIOR SPINAL FUSION AT L5-S1. NO MANUFACTURING ISSUE ASSOCIATED WITH REPORTED PRODUCTS. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188777 INFINITY APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 3606195 K23E1056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown