BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERA VOYAGER 5.5

    MDR report key: 24857409 · Received April 13, 2026

    Report

    Report Number
    3003120897-2026-00684
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 28, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HXX
    UDI-DI
    00643169754515
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 L5/6/S TLIF (TR ANSFORAMINAL LUMBAR INTERBODY FUSION) IT WAS REPORTED THAT AFTER INSERTION OF THE L6 RIGHT SCREW UNDER MAZOR, ADDITIONAL INSERTION WAS ATTEMPTED MANUALLY USING G170059 (CANNULATED RATCHET HANDLE) + 6555004 (SV56 BALL-END BONE SCREWDRIVER), BUT DID NOT ADVANCE DUE TO BONE SCLEROSIS; THE HANDLE WAS CHANGED TO 836-009 (RATCHET T-HANDLE) AND ADDITIONAL MANUAL INSERTION WAS ATTEMPTED, DURING WHICH THE TIP OF 6555004 (SV56 BALL-END BONE SCREWDRIVER) FRACTURED AND REMAINED INSIDE THE SCREW. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 3 APR 2026, UPDATE RECEIVED: POSTOPERATIVELY, THE PATIENT EXPERIENCED NUMBNESS IN THE RIGHT LOWER EXTREMITY. ACCORDING TO THE OPERATING SURGEON, THIS WAS ATTRIBUTED TO INTERVERTEBRAL FORAMINAL STENOSIS CAUSED BY EXCESSIVE COMPRESSION RELATED TO THE PRIOR PROCEDURE. ON (B)(6) 2026, A REVISION PROCEDURE WAS PERFORMED, WHICH INCLUDED ROD LOOSENING AND REPEAT DECOMPRESSION. ADDITIONAL DECOMPRESSION WAS CARRIED OUT, AND THE ROD WAS RE-SECURED USING NEW SET SCREWS. DURING THE REVISION PROCEDURE, THE PREVIOUSLY FRACTURED TIP OF THE SV56 BALL-END BONE SCREWDRIVER (PRODUCT 655004) AT THE RIGHT L6 SCREW WAS REMOVED AND RETRIEVED FROM THE BODY PRIOR TO ROD FIXATION. FOLLOWING RETRIEVAL, ROD FIXATION WAS COMPLETED AND THE PROCEDURE CONCLUDED. NO MALFUNCTION OF THE VOYAGER 5.5/6.0 IMPLANT PRODUCT HAS BEEN REPORTED. THE REPORTED NUMBNESS AND REVISION WERE CONFIRMED TO BE RELATED TO THE PATIENT¿S CONDITION AND PRIOR PROCEDURE, AND NOT DUE TO A MEDTRONIC ROD MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920985 SOLERA VOYAGER 5.5 SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC. 6550004 KH17A087 00643169754515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown