BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - RODS: EXPEDIUM/VIPER

    MDR report key: 24022591 · Received January 9, 2026

    Report

    Report Number
    1526439-2026-00025
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    January 1, 2025
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, 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 ARTICLE HAS BEEN REVIEWED: LEVY HA, HAMOUDA AM, MAGERA CA, KUMAR J, WILLSON C, GOH BC, BERNATZ JT, ELDER BD, FREEDMAN BA, SEBASTIAN AS. DO THREE-DIMENSIONAL PRINTED POROUS TITANIUM RELATIVE TO POLYETHERETHERKETONE INTERBODY CAGES REDUCE COMPLICATIONS AND REVISIONS AFTER TRANSFORAMINAL LUMBAR INTERBODY FUSION? GLOBAL SPINE J. 2025 MAY 19;16(1):21925682251339998. DOI: 10.1177/21925682251339998. EPUB AHEAD OF PRINT. PMID: 40387406; PMCID: PMC12089121. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO DETERMINE IF 3D PRINTED POROUS TITANIUM (TI) CAGES COMPARED TO NON-POROUS POLYETHERETHERKETONE (PEEK) CAGES PREDICTED IMPROVED FUSION RATE OR CLINICAL OUTCOMES AFTER TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). BETWEEN 2017-2021, A TOTAL OF 136 PATIENTS WITH 169 UNIQUE TLIF FUSION LEVELS (103 ONE-LEVEL, 33 TWO-LEVEL) MET THE INCLUSION/ EXCLUSION CRITERIA. SPECIFICALLY, 101 PATIENTS (125 TLIF LEVELS) UNDERWENT TLIF WITH 3DP POROUS TI INTERBODY CAGES AND 35 PATIENTS (44 TLIF LEVELS) WITH UNDERWENT TLIF WITH NON-POROUS PEEK INTERBODY CAGES. THE INTERBODY CAGE SYSTEMS UTILIZED WERE THE CONDUIT TITANIUM CAGE (DEPUY SYNTHES, RAYNHAM, MA, USA) AND OPAL AND T-PAL PEEK CAGES (DEPUY SYNTHES, RAYNHAM, MA, USA). ALL PATIENTS HAD POSTERIOR SUPPLEMENTAL FIXATION WITH EXPEDIUM® OR VIPER® PEDICLE SCREW SYSTEMS (DEPUY SYNTHES, RAYNHAM, MA, USA) AND ATTEMPTED POSTEROLATERAL FUSION. THERE WERE 60 (59.4%) FEMALES AND 41 (40.6%) MALES IN THE 3DP POROUS TI GROUP WITH THE MEAN AGE OF 67 [61.0, 73.0] YEARS. WHILE THERE WERE 19 (54.3%) FEMALES AND 16 (45.7%) MALES WITH THE MEAN AGE OF 65 [58.0, 73.0] YEARS IN THE NONPOROUS PEEK GROUP. THE AVERAGE RADIOGRAPHIC FOLLOW-UP DURATION IN THE OVERALL COHORT WAS 1.04 [0.99, 1.79] YEARS POSTOPERATIVELY. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES EIT CELLULAR TITANIUM CERVICAL CAGE AND SYNTHES EXPEDIUM® OR VIPER® PEDICLE SCREW SYSTEMS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CAGE/SPACER: CONDUIT EIT - TLIF (QTY 52): 6 PATIENTS HAD DURAL TEAR; NO INTERVENTION WAS NOTED. 2 PATIENTS HAD INFECTION, 1 PATIENT UNDERWENT REOPERATION. 1 PATIENT HAD HEMATOMA, UNDERWENT REOPERATION. 32 PATIENTS HAD ADJACENT SEGMENT DISEASE RATE, 13 PATIENTS UNDERWENT REOPERATION. 5 PATIENTS HAD PROXIMAL JUNCTIONAL KYPHOSIS; NO INTERVENTION WAS NOTED. 6 PATIENTS HAD REOPERATION DUE TO PSEUDOARTHROSIS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - RODS: EXPEDIUM/VIPER (QTY 1): 1 PATIENT HAD ROD FRACTURE; NO INTERVENTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506200 UNK - RODS: EXPEDIUM/VIPER ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown