BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25

    MDR report key: 14021289 · Received April 6, 2022

    Report

    Report Number
    3005180920-2022-00242
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812385
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04-APR-2022: LOT 2013778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2021. EXPIRATION DATE: 2026-01-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 8 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN AND X-RAYS SHOWED A SCREW IN THE OBTURATOR FORAMEN. THE SURGEON PERFORMED A RIGHT HIP HEAD AND LINER CHANGE WITH SCREW REMOVAL (TWO-HOLES CUP). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440482 MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 HIP CANCELLOUS BONE SCREW LPH MEDACTA INTERNATIONAL SA 01.32.6525 2013778 07630030812385

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention