BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTWIST

    MDR report key: 8266327 · Received January 22, 2019

    Report

    Report Number
    3025141-2019-00011
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Report Date
    January 4, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K930834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR'S ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00008: CASE 1; 3025141-2019-00009: CASE 2; 3025141-2019-00010: CASE 3.

    Description of Event or Problem · 1

    NONUNION AFTER IMPLANTATION OF AN ACUTWIST SCREW. ONE NONUNION IN PATIENT WITH LUPUS WHO UNDERWENT 3 ARTHRODESES. THE PATIENT REPORTED DISCOMFORT BUT NO REVISION SURGERY WAS PERFORMED. FROM: ARTHRODESIS OF THE THUMB INTERPHALANGEAL JOINT AND FINGER DISTAL INTERPHALANGEAL JOINTS WITH A HEADLESS COMPRESSION SCREW. CHRISTOPHER COX, MD, BRANDON E. EARP, MD, W. EMERSON FLYOD IV, BS, PHILIP E. BLAZARD, MD. J HAND SURG AM. 2014:39 (1): 24-28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58889 ACUTWIST SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1