BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM

    MDR report key: 20464547 · Received October 16, 2024

    Report

    Report Number
    3005180920-2024-00837
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 16, 2024
    Report Date
    November 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OUR
    UDI-DI
    07630971251496
    PMA / PMN Number
    K193083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2024. LOT: 2124492: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2022. EXPIRATION DATE: 2027-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: PEDICLE SCREW MUST S2AI HA SCREW Ø8X80 STD FULL THREAD (K234048) LOT: 2328888: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2024. EXPIRATION DATE: 2029-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    CORRECTION: H8 INITIAL USE.

    Description of Event or Problem · 0

    DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS TAPPING THE S2AI SCREW, HE COULD ONLY GET THE SCREW TO SEAT 80%. WHEN HE TRIED TO REMOVE THE SCREW WITH THE SCREWDRIVER, THE SCREWDRIVER BROKE. THE SURGEON TRIED ANOTHER SCREWDRIVER TO REMOVE THE SCREW WHICH ALSO BROKE. THE SURGEON TOOK A SAW AND CUT THE HEAD OFF THE SCREW AND LEFT THE SHAFT IN THE PATIENT. ADDITIONALLY, ON THE SI SCREW, THE SURGEON TRIED TO ADVANCE THE SCREW, AND THE IMPLANT FAILED 1/3 OF THE WAY DOWN. THE IMPLANT SHEARD OFF INSIDE THE DRIVER. THERE WAS A 45-MINUTE DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287737 M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM SPINE SACRAL ILIAC SCREW OUR MEDACTA INTERNATIONAL SA 03.65.659 2124492 07630971251496

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other