BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLUMIN8 INTEGR8 POROUS PEDICLE SCREW SYSTEM

    MDR report key: 25315730 · Received May 28, 2026

    Report

    Report Number
    3043234953-2026-00002
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ALLUMIN8 INC
    Product Code
    NKB
    UDI-DI
    10850062071039
    PMA / PMN Number
    K242827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION SHOWED THAT THE 5.5X40MM SCREWS AND THE 5.5X50MM SCREWS WERE MIS-ASSEMBLED DURING THE MANUFACTURING OF THE ASSEMBLY. SINCE THE SCREWS WERE MIS-ASSEMBLED WITH THE WRONG LENGTH, THE PACKAGING LABELING WAS NOT REPRESENTATIVE OF THE ACTUAL SCREW LENGTH.

    Description of Event or Problem · 0

    AFTER INSERTING THE SCREWS, THE SURGEON NOTED THAT THE SCREW LENGTHS WERE TOO LONG, SO HE EXPLANTED TWO OF THE SCREWS AND REPLACED THEM WITH OTHER SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163996 ALLUMIN8 INTEGR8 POROUS PEDICLE SCREW SYSTEM PEDICLE SCREW NKB ALLUMIN8 INC 0167-2508664 10850062071039

    Patients

    Seq Age Sex Outcome Treatment
    1