BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: VEPTR

    MDR report key: 25033830 · Received April 29, 2026

    Report

    Report Number
    8030965-2026-04013
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    August 27, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: 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: PIAZZA M, GUPTA VP, SPONSELLER PD, ANDRAS LM, CHEUNG KMC, GOMEZ JA, GUPTA P, PAHYS JM, SAMDANI AF, HWANG SW; PEDIATRIC SPINE STUDY GROUP. COMPLICATIONS OF GROWTH-FRIENDLY TECHNIQUES IN EARLY ONSET SCOLIOSIS OF NEUROFIBROMATOSIS TYPE 1: A CASE SERIES. CHILDS NERV SYST. 2025 AUG 27;41(1):268. DOI: 10.1007/S00381-025-06930-1. PMID: 40859068. OBJECTIVE/METHODS/STUDY DATA: IN THIS MULTICENTER RETROSPECTIVE STUDY, THE NEUROFIBROMATOSIS TYPE 1 (NF-1) IS A GENETIC DISEASE WITH MANY CLINICAL MANIFESTATIONS, INCLUDING EARLY ONSET SCOLIOSIS (EOS). THERE HAS BEEN INCREASING INTEREST IN THE USE OF GROWING ROD CONSTRUCTS IN THESE PATIENTS. THE STUDY SEEKS TO UNDERSTAND THE COMPLICATION RATES OF THESE PROCEDURES IN PATIENTS WITH NF-1. STUDY PERIOD IS UNKNOWN, THERE ARE THIRTEEN PATIENTS (8 MALES AND 5 FEMALES) WERE INCLUDED IN THE STUDY, EIGHT WITH DYSTROPHIC AND FIVE WITH NON-DYSTROPHIC SCOLIOSIS. PATIENTS UNDERWENT IMPLANTATION OF GROWTH-FRIENDLY CONSTRUCTS USING VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR), TRADITIONAL GROWING ROD (TGR),MAGNETICALLY CONTROLLED GROWING ROD (MCGR), AND ONE SHILLA. FOLLOW-UP WAS 2 YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES, VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: VEPTR (QTY (16) (N=6) PATIENTS HAD ANY PRE-FUSION COMPLICATION, NO INTERVENTION PROVIDED. (N=2) PATIENTS HAD INFECTION, NO INTERVENTION PROVIDED. (N=1) PATIENTS HAD NEUROLOGICAL COMPLICATION, NO INTERVENTION PROVIDED. (N=2) PATIENTS HAD OTHER COMPLICATION, NO INTERVENTION PROVIDED. (N=3) PATIENTS HAD EARLY FUSION AND REQUIRED SURGERY. (N=2) PATIENTS HAD UNPLANNED RETURN TO OPERATING ROOM UPROR (OTHER THAN FOR FUSION). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS (QTY 4) (N=4) PATIENT HAD INSTRUMENTATION FAILURE, NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41246 UNK - CONSTRUCTS: VEPTR PROSTHESIS, RIB REPLACEMENT MDI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention