BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9503888 · Received December 20, 2019

    Report

    Report Number
    3025141-2019-00645
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 12, 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: 3025141-2019-00643: CASE 1, 3025141-2019-00644: CASE 2, 3025141-2019-00646: CASE 4, 3025141-2019-00647: CASE 5, 3025141-2019-00648: CASE 6, 3025141-2019-00649: CASE 7.

    Description of Event or Problem · 1

    ARTICLE: OPEN REDUCTION AND PLATE FIXATION VERSUS NONOPERATIVE TREATMENT FOR DISPLACED MIDSHAFT CLAVICULAR FRACTURES; ROBINSON, C.M.; MURRAY, I.R.; JENKINS, P.J.; AHTAR, M.A.; READ, E.O.; FOSTER, C.J.; CLARK, K.; BROOKSBANK, A.J.; ARTHUR, A.; CROWTHER, M.A.; PACKHAM, I.; CHESSER, T.J. J BONE JOINT SURG AR. 2013; 95:1576-84. CASE 3: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED SUPERFICIAL WOUND INFECTION, TREATED WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298256 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention