BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 19228986 · Received May 2, 2024

    Report

    Report Number
    3025141-2024-00343
    Event Type
    Injury
    Date Received
    May 2, 2024
    Report Date
    April 30, 2024
    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 "PERCUTANEOUS INTRAMEDULLARY APPLICATION OF STEM CELLS FOR FIFTH METATARSAL FRACTURES TREATED WITH A CANNULATED SCREW" BY KOUKOULIAS, N.E., ET AL, THE AUTHORS STATE NON-UNION AND REFRACTURE OF FIFTH METATARSAL FRACTURES ARE COMMON AND DEVASTATING COMPLICATIONS IN THE ATHLETIC POPULATION. STEM CELL APPLICATION AT THE FRACTURE SITE, FOR BIOLOGIC ENHANCEMENT, IS UTILIZED TO ADDRESS THIS CHALLENGE. WE PRESENT A SIMPLE TECHNIQUE TO APPROACH BOTH THE ENDOSTEUM AND THE PERIOSTEUM PERCUTANEOUSLY, UNDER A LOCAL ANESTHETIC, IN CASES OF CANNULATED SCREW INTRAMEDULLARY FIXATION. THE AUTHORS PRESENTED A CASE OF A 22-YEAR-OLD, MALE, PROFESSIONAL BASKETBALL PLAYER WHO SUFFERED A PROXIMAL FIFTH METATARSAL FRACTURE. THE PATIENT FELT AN ACUTE PAIN IN HIS RIGHT FOOT AFTER LANDING FROM A JUMP, DURING PRACTICE. THE PATIENT WAS A NON-SMOKER AND HAD A CLEAR MEDICAL HISTORY. CLINICAL EXAMINATION REVEALED PROXIMAL FIFTH METATARSAL TENDERNESS AND EDEMA. THE ATHLETE WAS REFERRED FOR IMAGING STUDIES. RADIOGRAPHIC EVALUATION OF THE FOOT REVEALED A JONES FRACTURE. DUE TO HIS ATHLETIC PROFILE, SURGICAL TREATMENT WAS PLANNED, AND INTRAMEDULLARY SCREW FIXATION WAS PERFORMED TWO DAYS AFTER THE INJURY. AN ACUTRAK® 4/5, 45 MM IN LENGTH SCREW (ACUMED, LLC, HILLSBORO, USA) WAS INSERTED PERCUTANEOUSLY UNDER FLUOROSCOPY. POST-OPERATIVELY, THE FOOT WAS IMMOBILIZED IN A WALKING BOOT AND A STRUCTURED REHABILITATION REGIME WAS INITIATED. PARTIAL WEIGHT BEARING WITH CRUTCHES WAS ALLOWED ACCORDING TO PAIN TOLERANCE AND RANGE OF MOTION EXERCISES INITIATED ONE MONTH AFTER SURGERY. THE PATIENT WAS COMPLETELY ASYMPTOMATIC, WITH FULL WEIGHT BEARING AND FULL RANGE OF MOTION AT SIX WEEKS POST-OPERATIVELY AND THE BOOT WAS DISCONTINUED. IT WAS REPORTED RADIOGRAPHIC EVALUATION DEMONSTRATED UNCOMPLETED FRACTURE HEALING. THE PATIENT WAS NOT PERMITTED TO RETURN TO UNRESTRICTED ATHLETIC ACTIVITIES. CORE AND UPPER LIMB EXERCISES WERE ALLOWED ALONG WITH OPEN CHAIN LOWER LIMB EXERCISES IN ORDER TO PROTECT THE HEALING PROCESS. FOLLOW-UP RADIOGRAPHIC EVALUATION SHOWED NON-UNION OF THE FRACTURE AT TWELVE WEEKS POST [1]OPERATIVELY AND BIOLOGIC ENHANCEMENT OF THE HEALING PROCESS WITH STEM CELLS WAS DECIDED. THE OPTION OF REVISION, OPEN INTERNAL FIXATION WITH BONE GRAFTING WAS REJECTED AT THIS STAGE, DUE TO THE MORBIDITY OF THE PROCEDURE. THE FRACTURE WAS FOUND HEALED AT FOUR WEEKS POST-STEM CELL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858306 SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Other