BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 11146148 · Received January 11, 2021

    Report

    Report Number
    3025141-2020-00379
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Report Date
    December 14, 2020
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ARTICLE: EXPERIENCE IN THERAPY OF PROXIMAL HUMERAL FRACTURES USING INTRAMEDULLARY NAIL (POLARUS 3); KOICHIRO, NAKANISHI; YOSHIHISA, ANRAKU; YASHUJIRO, CHCHMI; SUGURU, ANDO; YOSHIKAZU, TAKEISHI; MASASHI, KAWAKAWA; KAZUHIKO, MUTO; AND MICHUNOBU, YONEMURA; ORTHOPEDICS AND TRAUMATOLOGY 67 (3) 575 - 578, 2018. CASE 1: PATIENT EXPERIENCED SCREW BACK OUT POST OP FOLLOWING IMPLANTATION OF A POLARUS 3 NAIL. THE PATIENT DID NOT EXPERIENCE ANY INCREASE IN TRANSPOSITION OR PAIN SO NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41354 SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1