BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24799790 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-01982
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    July 1, 2015
    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 2015 BY THE KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY, TITLED ¿A MATCHED-PAIR COMPARISON OF TWO DIFFERENT LOCKING PLATES FOR VALGUS-PRODUCING MEDIAL OPEN-WEDGE HIGH TIBIAL OSTEOTOMY: PEEK-CARBON COMPOSITE PLATE VERSUS TITANIUM PLATE". THE STUDY REVIEWED TWENTY SIX (26) PATIENTS WHO UNDERWENT OPENING WEDGE HIGH TIBIAL OSTEOTOMY (HTO) USING ARTHREX PEEKPOWER HTO PLATE (1ST GENERATION) TO ADDRESS VALGUS-PRODUCING MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMY (OWHTO). DURING THE THIRTY-ONE (31) MONTH FOLLOW-UP PERIOD, THREE(3) PATIENTS EXPERIENCED NONUNION. SOURCE: COTIC M, VOGT S, HINTERWIMMER S, ET AL. A MATCHED-PAIR COMPARISON OF TWO DIFFERENT LOCKING PLATES FOR VALGUS-PRODUCING MEDIAL OPEN-WEDGE HIGH TIBIAL OSTEOTOMY: PEEK-CARBON COMPOSITE PLATE VERSUS TITANIUM PLATE. KNEE SURG SPORTS TRAUMATOL ARTHROSC. JUL 2015;23(7):2032-40. DOI:10.1007/S00167-014-2914-8170.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858580 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other