BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 20333078 · Received September 30, 2024

    Report

    Report Number
    3004785967-2024-00573
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    June 9, 2024
    Report Date
    September 30, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE ACCEPTED DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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

    HENDRICKSON, N.R., HASELHUHN, J.J., ODLAND, K., SEMBRANO, J.N., MARTIN, C.T., JONES, K.E., POLLY, D.W. SACROPELVIC FIXATION WITH POROUS FUSION/FIXATION SCREWS: A TECHNICAL NOTE AND RETROSPECTIVE REVIEW. WORLD NEUROSURG. (2024) 190:172-180. HTTPS://DOI.ORG/10.1016/ J.WNEU.2024.06.046 - OBJECTIVE: THE GOAL OF THIS STUDY WAS TO ANALYZE OUR INITIAL EXPERIENCE USING A NOVEL POROUS FUSION/FIXATION SCREW (PFFS) FOR PELVIC FIXATION AND DETERMINE OUR RATE OF SCREW MALPOSITION REQUIRING INTRAOPERATIVE REPOSITIONING. - METHODS: WE REVIEWED 83 CONSECUTIVE PATIENTS WHO UNDERWENT SACROPELVIC FIXATION WITH PFFS AT OUR INSTITUTION FROM JUNE 1, 2022 TO JUNE 30, 2023 USING INTRAOPERATIVE COMPUTED TOMOGRAPHYEBASED COMPUTER-ASSISTED NAVIGATION VIA AN OPEN POSTERIOR APPROACH. FOLLOWING PFFS INSERTION, INTRAOPERATIVE COMPUTED TOMOGRAPHY SCANS WERE OBTAINED TO ASSESS SCREW POSITIONING. DEMOGRAPHIC DATA WERE COLLECTED, AND OPERATIVE REPORTS AND PATIENT IMAGES WERE REVIEWED TO DETERMINE WHAT IMPLANTS WERE USED AND IF ANY PFFS REQUIRED REPOSITIONING. - RESULTS: SEVENTY-FOUR PATIENTS (26M:48F) WERE INCLUDED, AND 57 (77.0%) HAD A PRIOR SACROILIAC JOINT OR LUMBAR SPINE SURGERY. A STACKED SCREW CONFIGURATION WAS USED IN 62/74 CASES (83.8%). A TOTAL OF 235 PFFS WERE USED AND SIX (2.6%) WERE MALPOSITIONED. OF 88 CEPHALIC SCREWS PLACED IN STACKED CONFIGURATION, 4 WERE MALPOSITIONED (4.5%) AND 1/123 CAUDAL SCREWS WERE MALPOSITIONED (0.8%). ONE OF 24 SACRAL-ALAR-ILIAC SCREWS PLACED IN A STAND-ALONE CONFIGURATION WAS MALPOSITIONED (4.2%). MALPOSITIONS INCLUDED 4 MEDIAL, 1 LATERAL, AND 1 INFERIOR, AND ALL WERE REVISED INTRAOPERATIVELY WITHOUT MAJOR SEQUELA. - CONCLUSIONS: ALTHOUGH PFFSS ARE LARGER THAN TRADITIONAL SACROPELVIC FIXATION SCREWS, STACKED SACRAL-ALARILIAC INSTRUMENTATION CAN BE DONE SAFELY WITH COMPUTERASSISTED NAVIGATION. WE FOUND A LOW MALPOSITION RATE IN OUR INITIAL SERIES OF PATIENTS, THE MAJORITY BEING THE CEPHALAD SCREW IN A STACKED CONFIGURATION. THIS ISN¿T SURPRISING, AS THESE ARE PLACED AFTER THE CAUDAL SCREWS, WHICH REDUCES THE AVAILABLE CORRIDOR SIZE AND INCREASES THE PLACEMENT DIFFICULTY REPORTED EVENTS: SIX (2.6%) WERE MALPOSITIONED. OF 88 CEPHALIC PFFS PLACED IN STACKED CONFIGURATION, 4 WERE MALPOSITIONED (4.5%), AND 1/123 CAUDAL PFFSS IN STACKED CONFIGURATION WERE MALPOSITIONED (0.8%). ONE OF 24 S2AI TRAJECTORY PFFS PLACED IN STAND-ALONE CONFIGURATION WAS MALPOSITIONED. ALL WERE GRADE 3 (>4 MM OF PERFORATION) BUT WERE ABLE TO BE REVISED INTRAOPERATIVELY WITH NO ADVERSE SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053989 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention