BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 24466197 · Received February 27, 2026

    Report

    Report Number
    2027754-2026-00009
    Event Type
    Injury
    Date Received
    February 27, 2026
    Report Date
    February 26, 2026
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    A LITERATURE REVIEW IDENTIFIED THE ARTICLE, MIRAJ F, KARDA I, NOOR EA. SUBTALAR ARTHROEREISIS AS A RELIABLE OPTION FOR FLEXIBLE FLATFOOT IN CHILDREN - A CASE SERIES. MALAYSIAN ORTHOPAEDIC JOURNAL. 2025 NOV;19(3):42-52. DOI: 10.5704/MOJ.2511.006. PMID: 41537030; PMCID: PMC12798132. THIS CASE SERIES EXPLORED THE USE OF SUBTALAR ARTHROEREISIS TO TREAT FLEXIBLE FLAT FOOT IN EIGHT (8) CHILDREN (15 FEET). THE MEAN AGE OF THE PATIENTS WAS 10.1 ± 0.8 YEARS, WITH 5 MALE AND 3 FEMALE PATIENTS. THE CHILDREN HAD A MEAN FOLLOW-UP OF 42.6 ± 9.7 MONTHS. ALL PATIENTS WERE TREATED WITH THE OSTEOMED TALAR-FIT IMPLANT. CLINICAL OUTCOMES WERE ASSESSED FOR THE AMERICAN ORTHOPAEDIC FOOT AND ANKLE SOCIETY (AOFAS) SCORE AND THE OXFORD ANKLE FOOT QUESTIONNAIRE FOR CHILDREN (OXAFQ-C). PATIENTS REPORTED AN AOFAS MEAN SCORE OF 87.0 ± 2.3 POSTOPERATIVE VERSUS 59.1 ± 1.8 PREOPERATIVE. SIMILAR RESULTS WERE SEEN FOR THE OXAFQ-C SCORE OF 21.7 ± 0.8 VERSUS 42.6 ± 2.6. ONE (1) PATIENT HAD IMPLANT MIGRATION ON HER RIGHT FOOT TO THE LATERAL SIDE TWO YEARS AFTER SURGERY. THIS RESULTED IN THE NAVICULAR INDEX TO INCREASE AND FOOT BECAME PRONATED AGAIN. HOWEVER, THE PATIENT REFUSED REVISION SURGERY. NO OTHER COMPLICATIONS WERE REPORTED. THE AUTHORS CONCLUDED THAT THE PATIENTS TREATED HAD AN OVERALL SATISFYING IMPROVEMENT IN CLINICAL FUNCTION AND GOOD RADIOLOGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527124 PLATE, FIXATION, BONE HRS OSTEOMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R