BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECA COMPRESSIVE 4.0 X 60MM-SN/A

    MDR report key: 23568641 · Received November 17, 2025

    Report

    Report Number
    MW5178935
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    June 3, 2025
    Report Date
    November 12, 2025
    Manufacturer
    NOVASTEP
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A NOVASTEP PECA COMPRESSIVE 4.0 X 60MM-SN/A, LOT NUMBER H0177A RIGHT, IMPLANTED IN MY RIGHT GREAT TOE ON (B)(6) 2024 AT (B)(6) HOSPITAL. DURING A FOLLOW UP X-RAY ON (B)(6) 2025 (DUE TO INCREASING PAIN IN MY FOOT), IT WAS DISCOVERED THE IMPLANT WAS COMPLETELY BROKEN. I WILL HAVE A REVISION SURGERY ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280114 PECA COMPRESSIVE 4.0 X 60MM-SN/A SCREW, FIXATION, BONE HWC NOVASTEP H0177A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other AMLODIPINE.| ARAVA.| CALCIUM W/VITAMIN D.| CIMZIA.| HYDROCHLOROTHIAZIDE.| METOPROLOL.| PANTOPRAZOLE.| VITAMIN C.