BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, 10MM CLEAR STERILE INTERPHLEX

    MDR report key: 25009561 · Received April 27, 2026

    Report

    Report Number
    2027754-2026-00014
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 27, 2026
    Manufacturer
    OSTEOMED LLC
    Product Code
    KWH
    PMA / PMN Number
    K022886
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNCLEAR WHY THE DEVICE WAS USED AFTER IT HAD PASSED ITS EXPIRATION DATE. NO FURTHER ACTION WAS REPORTED AFTER THIS INITIAL INCIDENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAIABLE, IT WILL BE SUBMITTED AS A FOLLOW UP.

    Description of Event or Problem · 0

    IT WAS REPORTED: A FACILITY HAS INFORMED US THAT AN EXPIRED INTERPHLEX IMPLANT WAS INADVERTENTLY INSERTED INTO A PATIENT. THE INTERPHLEX IMPLANT EXPIRED ON (B)(6) 2026, AND WAS INSERTED ON (B)(6) 2026. ITS BATCH NUMBER IS 1168523.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626437 IMPLANT, 10MM CLEAR STERILE INTERPHLEX PROSTHESIS, TOE, CONSTRAINED, POLYMER KWH OSTEOMED LLC 360-2810 1168523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other