BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - CAGE/PLATE: SYNFIX EVOLUTION

    MDR report key: 21871975 · Received April 21, 2025

    Report

    Report Number
    8030965-2025-03685
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    February 22, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY : PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SZABÓ V, BERTA B, NAGY M, KULCSÁR D, PERLAKI G, SCHWARCZ A. THE ALTERNATIVE APPROACH TO THE LUMBOSACRAL SEGMENT: THE RIGHT-SIDED OBLIQUE LUMBAR INTERBODY FUSION COMPARED WITH ANTERIOR LUMBAR INTERBODY FUSION. WORLD NEUROSURG. 2025 FEB 22;196:123823. DOI: 10.1016/J.WNEU.2025.123823. EPUB AHEAD OF PRINT. PMID: 39993623. OBJECTIVE/METHODS/STUDY DATA: THIS SINGLE-CENTER STUDY AIMED TO DEMONSTRATE THE FEASIBILITY AND SAFETY OF THE RIGHT-SIDED (LEFT LATERAL DECUBITUS POSITION) LUMBOSACRAL OLIF APPROACH COMPARED WITH THE CLASSIC ALIF TECHNIQUE BASED ON CLINICAL AND RADIOLOGICAL MEASURES. BETWEEN FEBRUARY 2018 AND FEBRUARY 2020, A TOTAL OF 21 PATIENTS (4 MALE AND 17 FEMALE) WITH A MEAN AGE OF 47.2+/-10.3 [18-63] UNDERWENT CLASSIC ALIF SURGERY (JOHNSON AND JOHNSON, DEPUY SYNTHES, AND SYNFIX EVOLUTION CAGE) IN THE LUMBOSACRAL SEGMENT SUPPLEMENTED WITH DORSAL PERCUTANEOUS PEDICLE SCREW FIXATION. THE FOLLOW-UP DURATION WAS 18.4+/-8.9 [8-40] MONTHS. FURTHERMORE, BETWEEN 2016 AND 2022, A TOTAL OF 20 PATIENTS (9 MALE AND 11 FEMALE) WITH A MEAN AGE OF 54.2+/-10.5 [37-77] WERE OPERATED ON WITH THE RIGHT-SIDED LUMBOSACRAL OLIF APPROACH RECEIVING SUPPLEMENTARY DORSAL PERCUTANEOUS PEDICLE SCREW FIXATION. THE FOLLOW-UP DURATION WAS 21.4+/-21.2 [7-84] MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES SYNFIX EVOLUTION CAGE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CAGE/PLATE: SYNFIX EVOLUTION (QTY 1). 1 PATIENT SHOWED SUBSIDENCE WHICH WAS LESS THAN 25%. IN THIS CASE, A GRADE II FUSION WAS FORMED. NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351969 UNK - CAGE/PLATE: SYNFIX EVOLUTION INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown