BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9527107 · Received December 27, 2019

    Report

    Report Number
    3025141-2019-00698
    Event Type
    Injury
    Date Received
    December 27, 2019
    Report Date
    December 23, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00699: CASE 2, 3025141-2019-00700: CASE 3.

    Description of Event or Problem · 1

    ARTICLE: PRECONTOURED PLATING OF CLAVICLE FRACTURES - DECREASED HARDWARE-RELATED COMPLICATIONS?; VANBEEK, CORINNE, MD; BOSELLI, KAREN J., MD; CADET, EDWIN R., MD; AHMAD, CHRISTOPHER S., MD; LEVINE, WILLIAM N., MD; CLIN ORTHOP RELAT RES (2011) 469:3337-3343. CASE 1: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED ADHESIVE CAPSULITIS WHICH WAS MANAGED NONOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319802 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention