BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35

    MDR report key: 9165881 · Received October 8, 2019

    Report

    Report Number
    3005180920-2019-00864
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812408
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2019: LOT 168798: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2017. EXPIRATION DATE: 2022-02-13. 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. ADDITIONAL IMPLANT INVOLVED IN THIS EVENT: SCREWS: MPACT 01.32.6535 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 45 (K103721) LOT. 115666A, BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2019: LOT 115666A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JULY-2017. EXPIRATION DATE: 2022-07-16. 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 SCREW IMPLANTATION THE FIRST ONE WENT OVER THE HOLE AND THE SECOND ONE REMAINED NOT TOTALLY SCREWED IN THE CUP HOLE. THE SURGEON DECIDED TO REMOVE THE SCREWS AND TO LEFT THE CUP IN PLACE WITHOUT SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963783 SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35 ACETABULAR BONE SCREW LPH MEDACTA INTERNATIONAL SA 168798 07630030812408

    Patients

    Seq Age Sex Outcome Treatment
    1 Other