BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 24615176 · Received March 17, 2026

    Report

    Report Number
    3003120897-2026-00530
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    November 13, 2025
    Report Date
    March 17, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. D4: PRODUCT IDENTIFIERS ARE UNKNOWN; HENCE 510K IS UNKNOWN. G2: COUNTRY OF ORIGIN IS CHINA. 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. CITATION: DEVELOPMENT OF A LASSO DYNAMIC PREDICTION SYSTEM FOR INTERBODY CAGE SUBSIDENCE FOLLOWING OLIF SURGERY. JIN ZHANG, HETONG LI, GUOFANG FANG, ZIWEN ZHU, XIUWANG LI, YANG CHEN, ZUOXU HOU, WEIDA ZHUANG, YUBAO LIU, JIANWEI WANG, JINTAO ZHONG, SHANRUI LIU, ELVIS CHUN-SING CHUI, WILLIAM WEIJIA LU, LINGQIN, WING-HOI CHEUNG, KELU HONGXUN SANG. DOI: HTTPS://DOI.ORG/10.1038/S41746-025-02019-W. 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 ¿DEVELOPMENT OF A LASSO DYNAMIC PREDICTION SYSTEM FOR INTERBODY CAGE SUBSIDENCE FOLLOWING OLIF SURGERY.¿ THE FOLLOWING MEDTRONIC DEVICES WERE USED: MEDTRONIC CLYDESDALE SPINAL SYSTEM INTERBODY CAGES AND PIVOX¿M OBLIQUE LATERAL SPINAL SYSTEM FIXATION COMPONENTS, ALONG WITH OTHER MEDTRONIC SOFAMOR DANEK, INC. PRODUCTS USED DURING OLIF PROCEDURES. AMONG PATIENTS, THE PRIMARY DEVICE-RELATED ADVERSE EVENT/DEVICE PERFORMANCE ISSUE REPORTED WAS INTERBODY CAGE SUBSIDENCE, WHICH OCCURRED IN 45.7% OF SURGICAL SEGMENTS AND 50.9% OF PATIENTS, PREDOMINANTLY MILD (GRADE I) IN SEVERITY. A SMALL NUMBER OF CASES WERE CLASSIFIED AS MODERATE (GRADE II) OR SEVERE (GRADE III). INTRAOPERATIVE ENDPLATE INJURY WAS IDENTIFIED AS A SIGNIFICANT CONTRIBUTING FACTOR TO SUBSIDENCE. SOME PATIENTS WITH SUBSIDENCE REPORTED MILD LOW BACK PAIN DURING FOLLOW-UP. FUSION RATES AND OVERALL CLINICAL OUTCOMES WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN PATIENTS WITH AND WITHOUT SUBSIDENCE. NO ADDITIONAL MEDTRONIC DEVICE PERFORMANCE ISSUES WERE DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684731 UNKNOWN INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC. MSB_UNK_CAGE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown