BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLUMIN8 INTEGR8 POROUS PEDICLE SCREW SYSTEM

    MDR report key: 25315727 · Received May 28, 2026

    Report

    Report Number
    3043234953-2026-00001
    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
    10850062071053
    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

    DURING A POST-OP REVIEW OF THE X-RAY IT WAS NOTICED THAT THE ALLUMIN8 SCREWS LOOKED SHORTER THAN THE OTHER COMPANY'S SCREWS WHICH WERE 50MM IN LENGTH. THE A8 BOX THAT WAS OPENED SAID THEY ARE 5.5 X 50 MM SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163879 ALLUMIN8 INTEGR8 POROUS PEDICLE SCREW SYSTEM PEDICLE SCREW NKB ALLUMIN8 INC LOT0168-2508665 10850062071053

    Patients

    Seq Age Sex Outcome Treatment
    1