BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW LOCKING TOWER ENH 2019

    MDR report key: 19086099 · Received April 11, 2024

    Report

    Report Number
    3005180920-2024-00216
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 6, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971256538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2024 LOT 2256325: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, OTHER 3 SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW (IN THE SAME COMPLAINT) ADDITIONAL INSTRUMENTS INVOLVED BATCH REVIEW PERFORMED ON (B)(6) 2024 ON PEDICLE SCREW 03.51.10.0583 LOCKING TOWER ENH 2019 LOT. 2157553 LOT 2157553: 8 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW (IN THE SAME COMPLAINT). BATCH REVIEW PERFORMED ON 20 MARCH 2024 ON PEDICLE SCREW 03.51.10.0583 LOCKING TOWER ENH 2019 LOT. 1955445 LOT 1955445: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 20 MARCH 2024 ON PEDICLE SCREW 03.51.10.0583 LOCKING TOWER ENH 2019 LOT. 2154100 LOT 2154100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA SPINE R&D PROJECT MANAGER: ONE PIECE OF LOT 2256325 IS CONFORM AND DOESN'T PRESENT ANY SIGN OF DAMAGE. ALL OTHER PIECES HAVE A BROKEN PLATINE AND/OR BROKEN FLAP. THIS MAY HAVE BEEN CAUSED BY NOT OPTIMAL ALIGNMENT BETWEEN THE INSTRUMENT AND THE PEDICLE SCREW HEAD, DURING REDUCTION OPERATION: IF THIS HAPPENS, THE RETAINING PINS DON'T ENTER THE RESPECTIVE SOCKET IN THE HEAD, LEADING TO EXCESSIVE LOAD ON THE WELDING. MODIFICATIONS HAVE BEEN INTRODUCED TO WELDINGS INDICATIONS AND INSPECTION METHOD TO IMPROVE THE MANUFACTURING PROCESS AND POTENTIALLY REDUCE FAILURE EVENTS. E1 ADDED COUNTRY. IT IS (B)(6) .

    Description of Event or Problem · 0

    THE PLATINE PART OF 8 DIFFERENT LOCKING TOWER ENH 2019 WAS BROKEN DURING SURGERY. DELAY TIME 1 HOUR AND A HALF (TOTAL TIME 4 HOURS). SURGERY COMPLETED SUCCESSFULLY ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262882 PEDICLE SCREW LOCKING TOWER ENH 2019 SPINE SURGICAL INSTRUMENT LXH MEDACTA INTERNATIONAL SA 2256325 07630971256538

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other