BEUDAMED
    FDA Adverse Event Death Summary report: N

    MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN

    MDR report key: 16633976 · Received March 29, 2023

    Report

    Report Number
    3005180920-2023-00212
    Event Type
    Death
    Date Received
    March 29, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 29, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278523
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 MAR 2023. LOT 2125491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2022. EXPIRATION DATE: 2027-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER ITEMS OF THE SAME LOT HAVE BEEN SOLD. ADDITIONAL COMPONENT INVOLVED: MUST LT 03.57.034 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X40 CANN (K203482) LOT 2227031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-09-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MUST LT 03.57.034 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X40 CANN (K203482) LOT. 2224926: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2022. EXPIRATION DATE: 2027-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    A MEDTRONIC'S SOLERA SCREW WAS PLACED ON L4/L5 AT THE PRIMARY SURGERY (WE DO NOT KNOW WHEN AND WHERE WAS PERFORMED). L5 RT SCREW SEEMS LIKE ALREADY LOOSENED OR MISPLACED. AFTER THE REMOVING OF THE EXISTING SCREW, THE MUST LT 7MM SCREW WAS PLACED BUT IT WAS NOT SECURED OR TIGHTENED ENOUGH SO THE SURGEON DECIDED TO REPLACE WITH MUST LT 8MM SCREW. WHEN THE 7MM LT SCREW WAS REMOVED, BLOOD BLEEDING WAS OBSERVED SO THE SURGEON PRESSED IT OVER AND STOPPED IT. THEN MUST LT 8MM SCREW WAS PLACED. ONCE IT WAS PLACED AND TRIED TO PUT THE SETSCREW, THEN THE LT SCREW WAS BACKED OUT. THE SURGEON DECIDED TO REMOVE THE 8MM LT SCREW AND LEFT WITHOUT ANY SCREW ON L5 RT, THEN STARTED TO CLOSE THE WOUND, BUT REALIZED THE BLEEDING WAS NOT STOPPED YET. THE PATIENT WAS TAKEN TO AN EMERGENCY HOSPITAL AND DIED THE DAY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953849 MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.57.044 2125491 07630971278523

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death