BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON LEGACY

    MDR report key: 19774688 · Received July 18, 2024

    Report

    Report Number
    1030489-2024-00857
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    November 17, 2023
    Report Date
    July 18, 2024
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS PUBLISHED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. D.4, G.4 PRODUCT IDENTIFIERS ARE UNKNOWN. H6 - NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. MARINA ROSA FILEZIO, ALEJANDRO PEIRO-GARCIA, DAVID LLEWELLYN PARSONS, KENNETH THOMAS, FABIO FERRI-DE-BARROS. 'ACCURACY OF IMAGING GRADING IN COMPARISON TO OPEN LAMINECTOMY TO EVALUATE PEDICLE SCREWS POSITIONING' ANNALS OF MEDICINE SURGERY. 2024, 86:199¿206. HTTP://DX.DOI.ORG/10.1097/MS9.0000000000001515 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

    LITERATURE WAS REVIEWED REGARDING ACCURACY OF IMAGING GRADING IN COMPARISON TO OPEN LAMINECTOMY TO EVALUATE PEDICLE SCREWS POSITIONING. THE FOLLOWING MEDTRONIC DEVICES WERE USED: CD HORIZON LEGACY (MEDTRONIC) PEDICLE SCREWS. FIVE SPINE SURGEONS(THREE ORTHOPAEDIC SURGEONS AND TWO NEUROSURGEONS) PERFORMED POSTERIOR SPINE INSTRUMENTATION (PSI) ON 20 SIMULATION SPINE MODELS. IN EACH MODEL, SCREWS WERE PLACED FROM T3 TO T7. TWO HUNDRED PEDICLE SCREWS WERE INSTRUMENTED USING FOUR DIFFERENT SURGICAL TECHNIQUES [FREEHAND PEDICLE PROBE (FH-P), FREEHAND GUIDED DRILLING (FH-D), NAVIGATED PEDICLE PROBE (N-P), AND NAVIGATED SEQUENTIAL DRILLING. IT WAS FOLLOWED BY RADIOGRAPHIC AND CT IMAGES ACQUIRED WITH THE ASSISTANCE OF THE O-ARM WHICH WERE EVALUATED BY THREE INDEPENDENT RATERS. FORTY-EIGHT BREACHES WERE IDENTIFIED IN THE AXIAL DIRECT VIEW AFTER LAMINECTOMY. OF THOSE, EIGHTEEN BREACHES WERE CLASSIFIED AS UNACCEPTABLE. REGARDING THE SAGITTAL DIRECT VIEW, FOUR BREACHES WERE OBSERVED, THREE OF WHICH WERE CLASSIFIED AS UNACCEPTABLE. THE FREQUENCY OF MISSED BREACHES BY ALL THREE EXAMINERS WAS HIGH, PARTICULARLY IN THE SAGITTAL PLANE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551576 CD HORIZON LEGACY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG MSB_UNK_SCREW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown