BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN

    MDR report key: 12127997 · Received July 7, 2021

    Report

    Report Number
    3005180920-2021-00546
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 4, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971279544
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JULY 2021, LOT 2022553: 70 ITEMS MANUFACTURED AND RELEASED ON 01-MARCH-2021. EXPIRATION DATE: 2026-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: MUST LT 03.59.235 MUST LT 25MM LONG - PEDICLE SCREW Ø7X45 CANN (K203482) LOT. 2022559, BATCH REVIEW PERFORMED ON 05 JULY 2021. LOT 2022559: 57 ITEMS MANUFACTURED AND RELEASED ON 01-MARCH-2021. EXPIRATION DATE: 2026-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR EVENT REPORTED ON THIS LOT. NOTE THAT TWO EQUAL DEVICES HAVE BEEN REPORTED IN THIS CASE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR A PATIENT OF BI-LEVEL LUMBAR FIXATION COMPLAINS ABOUT PAIN FEW WEEKS AFTER SURGERY. THE SCREWS ON THE LEFT SIDE WERE REMOVED AND NOT REPLACED. THE CAUSE OF PAIN IS UNKNOWN, BUT THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN ON THE LEFT SIDE AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REMOVED THREE SCREWS FROM THE PATIENT'S LEFT SIDE AND DID NOT IMPLANT ANYTHING TO REPLACE THEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028104 MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.59.225 2022553 07630971279544

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention