BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PECA2.0

    MDR report key: 23932601 · Received December 31, 2025

    Report

    Report Number
    3010673777-2025-00042
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 31, 2025
    Manufacturer
    NOVASTEP SAS
    Product Code
    HWC
    PMA / PMN Number
    K143229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO OTHER SURGEONS HAVE REPORTED THIS TYPE OF DEFECT DESPITE THE USERS NUMBER, AND THE ISSUE APPEARS TO BE ISOLATED TO A SINGLE USER. AS NO SIMILAR ISSUES HAVE BEEN REPORTED BY OTHER USERS, IT IS CONSIDERED UNLIKELY THAT THIS IS A PRODUCT-RELATED ISSUE AND MORE LIKELY A USAGE-RELATED MATTER. THIS CONCLUSION CANNOT BE CONFIRMED, HOWEVER, AS THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS AND NO LOT NUMBER OR PRODUCT REFERENCE WAS PROVIDED TO ENABLE FURTHER INVESTIGATION. X-RAYS WERE NOT AVAILABLE.

    Description of Event or Problem · 0

    WE HAVE RECEIVED INFORMATION INDICATING THAT A METATARSAL FRACTURE OCCURRED DURING THE INSERTION OF SCREW PECA2.0. THIS EVENT TOOK PLACE ON (B)(6) 2025. X-RAYS WERE NOT AVAILABLE AND WERE NOT SHARED DESPITE THE MULTIPLE REQUESTS, NO ADDITIONAL INFORMATION HAS BEEN COMMUNICATED TO US. NO LOT NUMBER OR PRODUCT REFERENCE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638740 PECA2.0 BEVELED COMPRESSIVE IMPLANT HWC NOVASTEP SAS NOT COMMUNICATED NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Other