BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24799598 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-01979
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    July 1, 2014
    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 2014 BY THE KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY, TITLED ¿PROSPECTIVE EVALUATION OF A NEW PLATE FIXATOR FOR VALGUS-PRODUCING MEDIAL OPEN-WEDGE HIGH TIBIAL OSTEOTOMY". THE STUDY REVIEWED TWENTY EIGHT (28) PATIENTS WHO UNDERWENT OPEN WEDGE HIGH TIBIAL OSTEOTOMY (HTO) USING ARTHREX PEEKPOWER HTO PLATE (2ND GENERATION) TO ADDRESS VALGUS-PRODUCING MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMY (OWHTO). DURING THE TWENTY FOUR (24) MONTH FOLLOW-UP PERIOD, ONE(1) PATIENT EXPERIENCED NONUNION. SOURCE: COTIC M, VOGT S, FEUCHT MJ, ET AL. PROSPECTIVE EVALUATION OF A NEW PLATE FIXATOR FOR VALGUS-PRODUCING MEDIAL OPEN-WEDGE HIGH TIBIAL OSTEOTOMY. KNEE SURG SPORTS TRAUMATOL ARTHROSC. DEC 2015;23(12):3707-16. DOI:10.1007/S00167-014-3287-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858584 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other