BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - BIOMATERIAL - CEMENT: VERTECEM V+

    MDR report key: 24885185 · Received April 15, 2026

    Report

    Report Number
    8030965-2026-03476
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHINOHARA A, KANAI T, KATSUMI S, OBATA S, WAKIYA H, TSUZUKI T, SAITO M. CEMENT LEAKAGE IN CEMENT-AUGMENTED FENESTRATED PEDICLE SCREWS FOR OSTEOPOROTIC SPINE: RISK STRATIFICATION WITH QUANTITATIVE COMPUTED TOMOGRAPHY ANALYSIS. J CLIN MED. 2025 NOV 18;14(22):8178. DOI: 10.3390/JCM14228178. PMID: 41303212; PMCID: PMC12653419. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO CLARIFY THE FREQUENCY AND PATTERNS OF CEMENT LEAKAGE ASSOCIATED WITH CEMENT-AUGMENTED FENESTRATED PEDICLE SCREWS (CAFPSS), TO IDENTIFY QUANTITATIVE RISK FACTORS THAT MAY ASSIST INTRAOPERATIVE DECISION-MAKING, AND TO PROVIDE FUNDAMENTAL DATA THAT COULD CONTRIBUTE TO NAVIGATION SUPPORT, INTEGRATION WITH ARTIFICIAL INTELLIGENCE (AI) TECHNOLOGIES, AND THE ESTABLISHMENT OF SAFER SURGICAL TECHNIQUES. BETWEEN MARCH 2022 TO DECEMBER 2024, 79 PATIENTS (65 FEMALES, 14 MALES; MEAN AGE WAS76.8 ± 8.38 YEARS) WERE INCLUDED WITH OSTEOPOROTIC VERTEBRAL FRACTURES OR DEGENERATIVE SPINAL DISEASES ASSOCIATED WITH OSTEOPOROSIS-RELATED BONE FRAGILITY, WHO UNDERWENT POSTERIOR SPINAL FIXATION USING CAFPSS. A TOTAL OF 302 SCREWS WERE ANALYZED. THE SCREW SYSTEMS USED WERE THE EXPEDIUM VERSE OR VIPER PRIME FENESTRATED SCREW SYSTEM WITH VERTECEM V+ CEMENT (DEPUY SYNTHES, RAYNHAM, MA, USA). CAFPSS WERE APPLIED ONLY IN CASES WITH OSTEOPOROSIS REQUIRING POSTERIOR FIXATION OF =2 LEVELS, WITH A MAXIMUM OF 2 VERTEBRAE (4 SCREWS) PER PATIENT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES VERTECEM V+ CEMENT OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: EXPEDIUM VERSE & VIPER PRIME FENESTRATED SCREW SYSTEM ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: VERTECEM V+ (QTY 46): -(N=46) CEMENT LEAKAGE WAS OBSERVED WHERE ALL CASES INVOLVED LEAKAGE INTO SEGMENTAL VEINS (TYPE S); NO TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103459 UNK - BIOMATERIAL - CEMENT: VERTECEM V+ CEMENT, BONE, VERTEBROPLASTY NDN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1