BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN

    MDR report key: 13541822 · Received February 16, 2022

    Report

    Report Number
    3005180920-2022-00100
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    January 17, 2022
    Report Date
    February 16, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971279605
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 FEBRUARY 2022. LOT 2022558: (B)(4). EXPIRATION DATE: 2026-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 09 FEBRUARY 2022. MUST LT 03.59.235 MUST LT 25MM LONG - PEDICLE SCREW Ø7X45 CANN (K203482) LOT 2120686: (B)(4). EXPIRATION DATE: 2026-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE MUST LT PEDICLE SCREWS HAD SHIFTED AFTER INSERTION DUE TO POOR BONE QUALITY. THE SURGEON REVISED THE SCREWS WITH COMPETITOR COMPONENTS 2 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472752 MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.59.234 2022558 07630971279605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention