BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY¿ OCCIPITOCERVICAL UPPER THORACIC SYSTEM

    MDR report key: 24143369 · Received January 22, 2026

    Report

    Report Number
    2647346-2026-00030
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 5, 2026
    Report Date
    April 9, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., HU
    Product Code
    KWP
    UDI-DI
    00763000196691
    PMA / PMN Number
    K163375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS : PART # G3604528: LOT # H5869201 VISUAL AND FUNCTIONAL INSPECTION CONFIRMED THE SCREW WAS ABLE TO ATTACH SECURELY TO A SAMPLE DRIVER WITHOUT ANY ISSUE. THE SCREW IS MADE TO PIVOT IN THE HEAD OF THE SCREW. NO FAULT FOUND. 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

    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 C7-TH2 POSTERIOR FIXATION; C3-6 LAMINOPLASTY; DECOMPRESSION OF TH1-3 DUE TO OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. IT WAS REPORTED THAT EVEN AFTER BEING ATTACHED TO THE NAV SCREWDRIVER, THE TIP REMAINED UNSTABLE. IT WAS THOUGHT TO BE AN ISSUE WITH THE METHOD OF INSERTION, BUT EVEN WHEN ATTEMPTED BY THE PHYSICIAN, IT COULD NOT BE PROPERLY SECURED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207478 INFINITY¿ OCCIPITOCERVICAL UPPER THORACIC SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC PUERTO RICO OPERATIONS CO., HU G3604528 H5869201 00763000196691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown