BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 17392240 · Received July 25, 2023

    Report

    Report Number
    3025141-2023-00383
    Event Type
    Injury
    Date Received
    July 25, 2023
    Report Date
    July 25, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS 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 COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IN THE ARTICLE " COMPARISON OF MAGNESIUM VERSUS TITANIUM SCREW FIXATION FOR BIPLANE CHEVRON MEDIAL MALLEOLAR OSTEOTOMY IN THE TREATMENT OF OSTEOCHONDRAL LESIONS OF THE TALUS" BY ACAR ET AL., A RETROSPECTIVE STUDY WAS PERFORMED TO COMPARE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF PATIENTS WHO UNDERWENT BIPLANE CHEVRON MEDIAL MALLEOLAR OSTEOTOMY (MMO) FOR OSTEOCHONDRAL LESIONS OF THE TALUS (OLT), FIXED WITH EITHER MAGNESIUM (MG) OR TITANIUM (TI) SCREWS. A TOTAL OF 22 PATIENTS (12 MALE AND 10 FEMALE) WHO UNDERWENT MMO FOR OLT TREATMENT WERE INCLUDED IN THIS RETROSPECTIVE STUDY. OF THE 22 PATIENTS, MMO WAS FIXED WITH BIOABSORBABLE MG SCREWS (DIFFERENT MANUFACTURER) IN 11 PATIENTS, AND IN THE REMAINING 11 PATIENTS (ONE BILATERAL) MMO WAS FIXED WITH TI SCREWS (ACUMED ACUTRAK SCREWS). IN THE TI GROUP, ONE PATIENT HAD COMPLAINTS OF PAIN AND IRRITATION OF THE SKIN BY PROMINENT SCREW HEADS. THE PATIENT'S DISCOMFORT WAS RELIEVED AFTER THE REMOVAL OF THE SCREW AT 22 MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809826 SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other