BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREWS

    MDR report key: 24207336 · Received January 29, 2026

    Report

    Report Number
    3008021110-2026-00114
    Event Type
    Injury
    Date Received
    January 29, 2026
    Report Date
    January 29, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBL
    UDI-DI
    08033390018869
    PMA / PMN Number
    K172456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBERS AS THOSE OF THE COMPONENTS INVOLVED IN THIS EVENT. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    PATIENT DEVELOPED AN INFECTION POST ON (B)(6) 2022 HIP SURGERY AND HAD A SURGICAL WASHOUT PROCEDURE. THE IMPLANT WAS NOT REMOVED. THEN ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN AND X-RAYS SHOW THAT THE SCREW FIXATION FAILED AND THE IMPLANT IS DISASSOCIATED FROM THE ACETABULUM. THE CORRECT DATE OF THE REVISION SURGERY IS CURRENTLY UNKNOWN. ACCORDING TO THE INFORMATION PROVIDED, THE COMPONENTS INVOLVED IN THIS EVENT ARE THE FOLLOWING: BONE SCREW Ø6,5 H.30MM (PART CODE: 8420.15.030, LOT NUMBER: 2114144, STERILIZATION: 2100225) BONE SCREW Ø6,5 H.35MM (PART CODE: 8420.15.040, LOT NUMBER: 2114894, STERILIZATION: 2100236) BONE SCREW Ø6,5 H.50MM (PART CODE: 8420.15.070, LOT NUMBER: 2105840, STERILIZATION: 2100171) BONE SCREW Ø6,5 H.60MM (PART CODE: 8420.15.090, LOT NUMBER: 2023272 / 1805396, STERILIZATION: 2100057 / 1800136). THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1957. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268953 BONE SCREWS BONE SCREWS DIA. 6.5 H.30MM MBL LIMACORPORATE S.P.A. 8420.15.030 2114144 08033390018869

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other