BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6105996 · Received November 16, 2016

    Report

    Report Number
    3005180920-2016-00586
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2016: LOT 161863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 MAY 2016. EXPIRATION DATE: 2021-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING SURGERY WHEN THE SURGEON WAS SCREWING THE SCREW INTO THE SHELL, THE HEAD OF THE SCREW BROKE OFF. THE HEAD WAS RECOVERED. THE SHAFT REMAINS IN THE PATIENT. THE SURGEON USED ANOTHER SCREW TO COMPLETE THE SURGERY. NO CRITICAL DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758498 MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 CANCELLOUS BONE SCREW LPH MEDACTA INTERNATIONAL SA 161863

    Patients

    Seq Age Sex Outcome Treatment
    1 Other