BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPS

    MDR report key: 24889780 · Received April 15, 2026

    Report

    Report Number
    1000525271-2026-00002
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 17, 2026
    Report Date
    March 16, 2026
    Manufacturer
    KLS-MARTIN L.P.
    Product Code
    JEY
    PMA / PMN Number
    K210731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POSSIBLE PRODUCTS IDENTIFIED: 60-000-72-09-LP LOT 8000284657 & 8000284659; 60-000-69-09-LP, LOT 8000284658.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MANDIBULAR HARDWARE WAS REMOVED FROM A PATIENT FOR UNKNOWN REASONS 10 WEEKS AFTER IMPLANTATION. THERE WERE NO REPORTED ISSUES WITH THE REMOVED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347454 IPS IMPLANT JEY KLS-MARTIN L.P. SEE H11 SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Other