BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 18448941 · Received January 4, 2024

    Report

    Report Number
    3025141-2024-00012
    Event Type
    Injury
    Date Received
    January 4, 2024
    Report Date
    January 4, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE MODEL NUMBER AND BATCH/LOT NUMBER ARE UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IN THE ARTICLE " ARTHRODESIS OF THE FIRST METATARSOPHALANGEAL JOINT FOR SEVERE HALLUX VALGUS IN ADOLESCENTS WITH CEREBRAL PALSY: A RETROSPECTIVE COMPARISON STUDY OF THREE SURGICAL TECHNIQUES" BY YE, K., ET AL, THE AUTHORS COMPARED THE OUTCOMES OF ARTHRODESIS OF THE FIRST METATARSOPHALANGEAL JOINT FOR SEVERE HALLUX VALGUS IN 31 ADOLESCENTS WITH CEREBRAL PALSY (CP), USING THREE DIFFERENT METHODS OF FIXATION: K-WIRES, NON-LOCKING PLATES, AND LOCKING PLATES. A RETROSPECTIVE ANALYSIS WAS PERFORMED ON DATA, WHICH HAD BEEN COLLECTED PROSPECTIVELY, FOR ADOLESCENTS WITH CP WHO HAD RECEIVED FIRST MTP ARTHRODESIS SURGERY FOR HALLUX VALGUS (HV) BETWEEN 2000 AND 2019, AT A SINGLE TERTIARY LEVEL, CHILDREN'S HOSPITAL. THE MEAN AGE AT TIME OF SURGERY WAS 15YEARS AND 10MONTHS (RANGE: 12YEARS AND 1MONTH-18YEARS AND 7MONTHS). A TOTAL OF 31 PATIENTS WERE EVALUATED IN THIS STUDY INCLUDING A TOTAL OF 59 OPERATIONS WITH MOST PATIENTS RECEIVING BILATERAL SURGERY. THREE GROUPS WERE IDENTIFIED: PLANAR JOINT PREPARATION AND K-WIRE FIXATION (DIFFERENT MANUFACTURER), CUP AND CONE REAMING FOR JOINT PREPARATION, AND EITHER NON-LOCKING MINIFRAGMENT PLATE FIXATION (DIFFERENT MANUFACTURER), OR LOCKING LOW-PROFILE, CONTOURED PLATE FIXATION (ACUMED®, HILLSBORO, OR, USA). THERE WERE 10 PATIENTS IN THE K-WIRE GROUP, 11 PATIENTS IN THE NON-LOCKING PLATE GROUP, AND 10 IN THE LOCKING PLATE GROUP. THIS ACUMED PRODUCT WAS PERFORMED IN A NON-TARGET PATIENT POPULATION. THE FOLLOWING COMPLICATION WAS REPORTED: THERE WAS ONE COMPLICATION IN THE LOCKING PLATE GROUP, A SUPERFICIAL STITCH ABSCESS THAT RESOLVED FOLLOWING SUTURE REMOVAL (MCD GRADE II).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627808 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other