BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSS VRS

    MDR report key: 22156527 · Received June 6, 2025

    Report

    Report Number
    8010944-2025-00002
    Event Type
    Injury
    Date Received
    June 6, 2025
    Report Date
    June 6, 2025
    Manufacturer
    BIEDERMANN MOTECH GMBH & CO KG
    Product Code
    NKB
    UDI-DI
    4250869654180
    PMA / PMN Number
    K203607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICE ARE INVOLVED: 1.) 1X 113-092-7040 MOSS XT TI PEDICLE SCREW Ø7.0X40MM, VIOLET, CANNULATED, DL, POLYAXIAL / BATCH: UNKNOWN. 2.) 5X 113-092-8045 MOSS XT TI PEDICLE SCREW Ø8.0X45MM, GOLD, CANNULATED, DL, POLYAXIAL / BATCH: UNKNOWN. 3.) 2X 112-064-0100 MOSS VRS MIS TI ROD XT Ø5.5X100MM, CURVED / BATCH: UNKNOWN. 4.) 6X 108-004-0004 MOSS VRS TI LOCKING CAP XT, STAR 27 / BATCH: UNKNOWN. 5.) 6X 112-017-0002 MOSS VRS MIS IN: SITU TI POLYAXIAL LONG HEAD, EXTENDED TABS / BATCH: UNKNOWN.

    Description of Event or Problem · 0

    ALMOST ONE YEAR AFTER THE INITIAL SURGERY A LOOSE SET SCREW WAS FOUND IN A ROUTINE FOLLOW UP EXAM BY X-RAY. THE SURGEON ELECTED TO REMOVE AND REPLACE THE ORIGINAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492385 MOSS VRS MOSS VRS TI LOCKING CAP NKB BIEDERMANN MOTECH GMBH & CO KG 4250869654180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other