BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT EXTENSION

    MDR report key: 24762676 · Received April 2, 2026

    Report

    Report Number
    3005180920-2026-00296
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630971257504
    PMA / PMN Number
    K200391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 23 MARCH 2026: SCREWS: MPACT 01.43.0040 CANCELLOUS BONE SCREW D 6,5 L40 (K200391) LOT 2312909: 80 ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2023. EXPIRATION DATE: 2028-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0035 CANCELLOUS BONE SCREW D 6,5 L35 (K200391) LOT 2319087: 80 ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2023. EXPIRATION DATE: 2028-AUG-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW D 6,5 L30 (K200391) LOT 2519084: 80 ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2025. EXPIRATION DATE: 2030-SEP-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 40 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT INITIALLY UNDERWENT PRIMARY SURGERY WITH COMPETITOR PRODUCTS. ON (B)(6) 2026, A REVISION WAS PERFORMED USING A MEDACTA MPACT CUP AND LINER. ON (B)(6) 2026, THE PATIENT PRESENTED WITH PAIN, WHICH WAS ATTRIBUTED TO EXCESSIVELY LONG SCREWS FROM THE PRIMARY SURGERY PROTRUDING INTO SURROUNDING SOFT TISSUE. THE SURGEON REVISED THE SCREWS, REPLACING L30, L35, AND L40 WITH SHORTER L15 AND TWO L20 SCREWS, AND ALSO EXCHANGED THE LINER WITH THE SAME SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REPORTED PAIN WAS CAUSED BY SOFT TISSUE IRRITATION DUE TO SCREW PROTRUSION. NO X-RAYS ARE AVAILABLE, ALTHOUGH THEY HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918 MPACT EXTENSION CANCELLOUS BONE SCREW Ø 6,5 L40 MEH MEDACTA INTERNATIONAL SA 01.43.0040 2312909 07630971257504

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention