BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE® SPINAL SYSTEM

    MDR report key: 24840632 · Received April 10, 2026

    Report

    Report Number
    3003120897-2026-00675
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MQP
    UDI-DI
    00613994803061
    PMA / PMN Number
    K103731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 L4-L5 REVISION AND REMOVAL OF EXISTING HARDWARE SOLERA 4.75 PEDICAL SCREWS AND ADAPTIX INTERBODY. SURGEON EXPOSED PATIENT REMOVING OLD SOLERA 4.75 SET SCREWS, RODS, AND PEDICLE SCREWS. SURGEON THEN EXPOSED TO THE EXISTING ADAPTIX INTERBODY AND TRIED TO ATTACH AND REMOVE WITH ORIGINAL ADAPTIX INSERTER. IT WAS REPORTED THAT SURGEON WAS REMOVING EXISTING ADAPTIX INTERBODY WITH PROPER INSERTER (2990001) HE THOUGHT IT WAS ATTACHED TO EXISTING INTERBODY IN PATIENT SO HE TWIST THE INSTRUMENT AND BROKE ONE OF THE TIPS OFF THAT ATTACHES AROUND THE IMPLANT. SURGEON DID MALLET THE INSERTER BEFORE TWISTING EVEN THOUGH HE WAS ADVISED NOT TO MALLET THE INSTRUMENT PER  TECHNIQUE. BROKEN TIP WAS REMOVED FROM PATIENT AND BROKEN INSERTER WAS REMOVED FROM SURGICAL FIELD. INTERBODY WAS REMOVED USING A UNIVERSAL  REMOVAL TOOL MAKING SURE ALL AND EVERYTHING WAS REMOVED FROM THE PATIENT. SURGEON TOOK A 3D IMAGE USING  O-ARM CHECKING NOTHING REMAINED IN THE PATIENT. SURGEON THEN PLACED NEW ADDITIONAL SOLERA 4.75 PEDICLE SCREWS, RODS, AND SETSCREWS. FINALLY SURGEON PERFORMED ANOTHER 3D IMAGE USING  O-ARM CONFIRMING EVERYTHING WAS REMOVED AND NEW SCREWS WERE PLACED PROPERLY. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537157 CAPSTONE® SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC. 2990001 KH21A034 00613994803061

    Patients

    Seq Age Sex Outcome Treatment
    1