BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - VEPTR IMPLANTS: LAMINA H

    MDR report key: 25057563 · Received May 1, 2026

    Report

    Report Number
    8030965-2026-04125
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    December 5, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    MDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (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: MLADENOV KV, STÜCKER R. RECENT DEVELOPMENTS IN SURGICAL TREATMENT OF SPINAL DEFORMITY IN PEDIATRIC PATIENTS: EXPERIENCE FROM A SINGLE-CENTER SERIES OF 42 NEUROFIBROMATOSIS TYPE 1 PATIENTS. CANCERS (BASEL). 2024 DEC 5;16(23):4079. DOI: 10.3390/CANCERS16234079. PMID: 39682265; PMCID: PMC11640448. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY IS TO SHARE THE EXPERIENCE AND TO REPORT THE OUTCOMES AFTER TREATMENT OF SPINAL DEFORMITIES IN PEDIATRIC PATIENTS WITH NF-1.BETWEEN 2006 AND 2024, THE STUDY GROUP COMPRISED 42 PATIENTS WITH A MEAN AGE AT SURGERY OF 9.8 YEARS. TWENTY-FIVE PATIENTS (60%) WERE TREATED BY MEANS OF GROWTH-PRESERVING TECHNIQUES (VEPTR IN 10; MCGRS IN 9 AND TGRS IN 6 PATIENTS) AND 17 PATIENTS (40%) BY MEANS OF DEFINITIVE FUSION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: VEPTR®. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS: LAMINA HOOK (QTY: (B)(4). 9-YEAR-OLD PATIENT HAD DISTAL MIGRATION OF THE LAMINAR CAUDAL ANCHOR WITH LOSS OF CORRECTION. NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504587 UNK - VEPTR IMPLANTS: LAMINA H PROSTHESIS, RIB REPLACEMENT MDI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown