BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - BIOMATERIAL - CEMENT: VERTECEM V+

    MDR report key: 21961247 · Received May 5, 2025

    Report

    Report Number
    8030965-2025-04529
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    May 27, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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. 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 REPORT, A FOLLOW-UP REPORT 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: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: 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: SÜVEGH D, JUHÁSZ Á, VIOLA R, AL-SMADI MW, VIOLA Á. TREATMENT OF ANKYLOSING SPONDYLITIS PATIENTS WITH CERVICAL SPINAL INJURY WITH ANTERIOR SINGLE-STAGE FIXATION WITH BONE CEMENT AUGMENTATION. J CLIN MED. 2024 MAY 27;13(11):3131. DOI: 10.3390/JCM13113131. PMID: 38892842; PMCID: PMC11172596. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ASSESS THE EFFECTIVENESS AND SAFETY OF SINGLE-STAGE PLATE STABILIZATION AND VENTRAL CEMENT AUGMENTATION FOR MANAGING SUBAXIAL CERVICAL SPINE FRACTURES IN PATIENTS WITH AS. BETWEEN NOVEMBER 2016 TO DECEMBER 2023, A COHORT OF 38 PATIENTS (26 MALES AND 12 FEMALES ; WITH A MEAN AGE OF 70.7 YEARS) WITH AS WHO SUFFERED TRAUMATIC SUBAXIAL CERVICAL SPINE INJURIES USING PLATE FIXATION WITH CEMENT AUGMENTATION VIA A VENTRAL APPROACH. DURING THE PROCEDURE, A 10 G VERTEBROPLASTY NEEDLE (DIAMOND TIP, DEPUY SYNTHES, WARSAW, IN, USA) WAS USED TO CAREFULLY INSERT VERTECEM V+ POLYMETHYL METHACRYLATE (PMMA) INTO THE VERTEBRAL BODIES ON THE RIGHT SIDE, AIMING TO INJECT A MAXIMUM OF 1.5 ML OF CEMENT IN A CONTROLLED MANNER UNDER RADIOLOGIC SUPERVISION WITH A C-ARM. FOLLOW-UP DURATION WAS 91 DAYS MINIMUM WHILE THE MAXIMUM WAS 2674 DAYS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES VERTECEM V+ POLYMETHYL METHACRYLATE (PMMA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: VERTECEM V+ (QTY: (B)(4). -27 CASES HAD CEMENT-LEAKAGE AT EPIDURAL SPINAL CANAL. NO INTERVENTION INDICATED. -9 CASES HAD CEMENT-LEAKAGE AT VERTEBRAL ARTERY AREA. NO INTERVENTION INDICATED. -3 CASES HAD CEMENT-LEAKAGE AT NEUROFORAMEN. NO INTERVENTION INDICATED. -15 CASES HAD CEMENT-LEAKAGE AT PARAVERTEBRAL SPACE. NO INTERVENTION INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831350 UNK - BIOMATERIAL - CEMENT: VERTECEM V+ POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown