BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 21261880 · Received January 29, 2025

    Report

    Report Number
    1030489-2025-00432
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 6, 2023
    Report Date
    January 29, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    UDI-DI
    00763000151249
    PMA / PMN Number
    K201362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 55751027550, LOT # H5882940 - VISUAL AND OPTICAL INSPECTION CONFIRMED THE SCREW WAS RETURNED BROKEN. THE BREAK OFF TABS ON BOTH SIDES OF THE SCREW HEAD PEDICLE HAVE BROKEN OFF AS INTENDED. THE SCREW HEAD PEDICLE HAS BROKEN ON ONE SIDE AND THE OTHER SIDE IS BENT. THE DAMAGE TO THE SCREW APPEARS TO BE FROM 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 UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW HEAD WAS BROKEN INTRA-OPERATIVELY. THE SCREW WAS EXPLANTED. THE PATIENT SUFFERED A LUMBAR SPINE FRACTURE WITH POST-TRAUMATIC KYPHOSIS IN A TRAFFIC ACCIDENT. THE DORSAL STABILIZATION OF BWK 11/12 TO LWK 2/3 TOOK PLACE, USING MONOAXIAL SCREWS FOR THE BWK 12 AND LWK 2 SEGMENTS. SUBSEQUENTLY, A REDUCTION (RESPIRATION AND DISTRACTION) WAS CARRIED OUT USING THE SPACE T SYSTEM. UNDERNEATH, THE TULIP OF THE MONOAXIAL SCREW IN LWK 2 BENT TO THE LEFT, SO THAT THE LOCKING NUT COULD NOT BE INSERTED PROPERLY. WHEN ATTEMPTING TO BREAK OFF THE LONGHEAD BLADE, THE CLEANING SITE DID NOT BREAK OFF PROPERLY. AFTER FURTHER MANIPULATION OF THE TUBE, IT BROKE OFF. THE SCREW WAS REMOVED AND REPLACED WITH A NEW MONO AXIAL PEDICLE SCREW. THE PATIENT DID NOT SUFFER ANY HARM AS A RESULT OF THIS INCIDENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817973 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55751027550 H5882940 00763000151249

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female