BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24794078 · Received April 6, 2026

    Report

    Report Number
    1220246-2026-01973
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    July 1, 2023
    Report Date
    April 6, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 12-MAR-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2023 BY THE EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, TITLED ¿MINIMUM 2-YEAR RESULTS OF THE SECOND-GENERATION CFR-PEEK LOCKING PLATE ON THE PROXIMAL HUMERAL FRACTURE". THE STUDY REVIEWED THIRTY (30) PATIENTS WHO UNDERWENT FRACTURE FIXATION USING PEEKPOWER HUMERAL FRACTURE PLATE (ARTHREX) TO ADDRESS PROXIMAL HUMERUS FRACTURES. DURING THE FIFTY-ONE (51) MONTH FOLLOW-UP PERIOD, ONE (1) PATIENT EXPERIENCED DECREASED RANGE OF MOTION/SHOULDER STIFFNESS RESULTING IN IMPLANT REMOVAL. SOURCE: DEY HAZRA RO, SZEWCZYK K, ELLWEIN A, ET AL. MINIMUM 2-YEAR RESULTS OF THE SECOND-GENERATION CFR-PEEK LOCKING PLATE ON THE PROXIMAL HUMERAL FRACTURE. EUR J ORTHOP SURG TRAUMATOL. MAY 2023;33(4):1307-1314. DOI:10.1007/S00590-022-03298-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853629 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other