BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPIPLASTY SYSTEM S4A

    MDR report key: 21610799 · Received March 14, 2025

    Report

    Report Number
    3011623994-2025-00023
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 14, 2025
    Report Date
    May 6, 2025
    Manufacturer
    TREACE MEDICAL CONCEPTS, INC.
    Product Code
    HRS
    UDI-DI
    00853114006327
    PMA / PMN Number
    K220136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: G4: 510K: K220136. H11: IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A FRACTURED MEDIAL CUNEIFORM AND SMASHED PROXIMAL MEDIAL METATARSAL BASE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REVISED WITH NON-TMC DEVICES. NO DEVICES WERE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION INDICATES THE SURGEON BELIEVES THE FRACTURE WAS CAUSED BY A TRAUMA INCIDENT THAT WAS REVEALED ON AN X-RAY TAKEN DURING A POST-OP FOLLOW-UP. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURE AND RELEASE OF THE DEVICES THAT COULD HAVE CONTRIBUTED TO WHAT WAS REPORTED. ALTHOUGH SEVERAL FACTORS CAN CONTRIBUTE TO THE REPORTED EVENT, THE MOST LIKELY CAUSE CANNOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED, AND NO DEVICE BEING RETURNED. HOWEVER, ADDITIONAL INFORMATION INDICATES THAT A POSSIBLE TRAUMA INCIDENT MAY HAVE CONTRIBUTED TO WHAT THE PATIENT EXPERIENCED. NO DEFICIENCIES OR MALFUNCTIONS HAVE BEEN ALLEGED/FOUND WITH ANY TMC DEVICE. THE COMPANY WILL SUPPLEMENT THIS MDR AS NECESSARY AND APPROPRIATE. ADDITIONAL TMC DEVICES EXPLANTED IN THE SAME REVISION SURGERY WERE REPORTED IN (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A FRACTURED MEDIAL CUNEIFORM AND SMASHED PROXIMAL MEDIAL METATARSAL BASE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REVISED WITH NON-TMC DEVICES. NO DEVICES WERE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION INDICATES THE SURGEON BELIEVES THE FRACTURE WAS CAUSED BY A TRAUMA INCIDENT THAT WAS REVEALED ON AN X-RAY TAKEN DURING A POST-OP FOLLOW-UP. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURE AND RELEASE OF THE DEVICES THAT COULD HAVE CONTRIBUTED TO WHAT WAS REPORTED. ALTHOUGH SEVERAL FACTORS CAN CONTRIBUTE TO THE REPORTED EVENT, THE MOST LIKELY CAUSE CANNOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED, AND NO DEVICE BEING RETURNED. HOWEVER, ADDITIONAL INFORMATION INDICATES THAT A POSSIBLE TRAUMA INCIDENT MAY HAVE CONTRIBUTED TO WHAT THE PATIENT EXPERIENCED. NO DEFICIENCIES OR MALFUNCTIONS HAVE BEEN ALLEGED/FOUND WITH ANY TMC DEVICE. THE COMPANY WILL SUPPLEMENT THIS MDR AS NECESSARY AND APPROPRIATE. ADDITIONAL TMC DEVICES EXPLANTED IN THE SAME REVISION SURGERY WERE REPORTED IN 3011623994_2025_00022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A FRACTURED MEDIAL CUNEIFORM AND SMASHED PROXIMAL MEDIAL METATARSAL BASE. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509603 LAPIPLASTY SYSTEM S4A PLATE HRS TREACE MEDICAL CONCEPTS, INC. SK39 300443300 00853114006327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention