BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24800515 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-01999
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    July 1, 2017
    Report Date
    April 7, 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 2017 BY THE EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, TITLED ¿.OUTCOMES OF PROXIMAL HUMERAL FRACTURE FIXATION WITH LOCKED CFR-PEEK PLATING". THE STUDY REVIEWED TWENTY ONE (21) PATIENTS WHO UNDERWENT FRACTURE FIXATION USING PEEKPOWER HUMERAL FRACTURE PLATE (ARTHREX) TO ADDRESS PROXIMAL HUMERUS FRACTURES. DURING THE TWELVE (12) MONTH FOLLOW-UP PERIOD, ONE(1) PATIENT EXPERIENCED IMPLANT IMPINGEMENT REQUIRING IMPLANT REMOVAL. SOURCE: KATTHAGEN JC, ELLWEIN A, LUTZ O, VOIGT C, LILL H. OUTCOMES OF PROXIMAL HUMERAL FRACTURE FIXATION WITH LOCKED CFR-PEEK PLATING. EUR J ORTHOP SURG TRAUMATOL. APR 2017;27(3):351-358. DOI:10.1007/S00590-016-1891-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858595 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other