BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 18022766 · Received October 27, 2023

    Report

    Report Number
    3025141-2023-00607
    Event Type
    Injury
    Date Received
    October 27, 2023
    Report Date
    October 26, 2023
    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

    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 PERI-IMPLANT FRACTURE OCCURRED BECAUSE OF THE PATIENT'S SEVERE OSTEOPOROSIS.

    Description of Event or Problem · 0

    IN THE ARTICLE " COMPARISON OF DISTAL RADIUS FRACTURE PLATING SURGERY UNDER WIDE-AWAKE LOCAL ANESTHESIA NO TOURNIQUET TECHNIQUE AND BALANCED ANESTHESIA: A RETROSPECTIVE COHORT STUDY" BY CHEN, CT, ET AL, THE AUTHORS REPORTED DISTAL RADIUS FRACTURES (DRF) ARE FREQUENTLY TREATED WITH INTERNAL FIXATION UNDER GENERAL ANESTHESIA OR A BRACHIAL PLEXUS BLOCK. PER THE AUTHORS, RECENTLY, THE WIDE-AWAKE LOCAL ANESTHESIA WITH NO TOURNIQUET (WALANT) TECHNIQUE HAS BEEN SUGGESTED AS A METHOD THAT RESULTS IN HIGHER PATIENT SATISFACTION. THIS STUDY AIMED TO EVALUATE THE FUNCTIONAL OUTCOMES, COMPLICATIONS, AND PATIENT-REPORTED OUTCOMES OF DRF PLATING SURGERY UNDER BOTH THE WALANT AND BALANCED ANESTHESIA (BA). VOLAR LOCKING PLATES FROM ACUMED (ACU-LOC PLATE, ACUMED, LLC) AND THREE OTHER MANUFACTURERS WERE USED FOR INTERNAL FIXATION. AN 82-YEAR-OLD WOMAN WHO HAD PREVIOUSLY UNDERGONE OPEN REDUCTION AND INTERNAL FIXATION OF HER LEFT DRF VIA THE WALANT TECHNIQUE BROKE HER RIGHT WRIST TWO YEARS LATER AND CHOSE TO UNDERGO THE SAME PROCEDURE AGAIN. PER THE AUTHORS, UNFORTUNATELY, A PERI-IMPLANT FRACTURE OCCURRED BECAUSE OF SEVERE OSTEOPOROSIS. AS THE MAXIMUM DOSE OF LIDOCAINE HAD ALREADY BEEN ADMINISTERED, THE SURGEON CONVERTED THE PROCEDURE TO BA AND USED A LONGER PLATE WITH AN EXTENDED WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132514 PLATE, FIXATION, BONE HRS ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other