BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW LOCKING TOWER ENH 2019

    MDR report key: 11862215 · Received May 21, 2021

    Report

    Report Number
    3005180920-2021-00405
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971256538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 3 MAY 2021: LOT 2052849: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: AFTER THE END OF THE SURGERY, IT WAS NOTICED THAT ONE OF THE PLATES OF REF 03.51.10.0583, LOT 2052849, DETACHED FROM THE INSTRUMENT. THE PARTS ARE NOT CONFORMING TO THE DRAWING SINCE THE WELDING OF THE PLATE ON THE INNER TUBE IS NOT COMPLETE. THE ROOT CAUSE OF THIS FAILURE MIGHT BE RELATED TO A WELDING PROBLEM. DURING THE VISUAL INSPECTION, IT WAS NOTICED THAT THE REMAINING PLATE IS NOT COMPLETELY WELDED TO THE INNER TUBE. IN PARTICULAR, IT LOOKED LIKE ONLY HALF OF THE PLATE IS WELDED, THE REMAINING PART IS NOT . IN ADDITION, AS IT IS POSSIBLE TO SEE FROM THE MICROSCOPE IMAGES OF THE INNER TUBE, THE LATERAL ZONE OF THE TUBE SEEMS DAMAGED. THIS MIGHT BE RELATED TO THE EXCESSIVE POWER OF THE LASER BEAM USED FOR THE WELDING. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: A SMALL METAL PARTICLE, FEW MM IN DIMENSION, IS TORN AWAY FROM AN INSTRUMENT DURING SPINAL SCOLIOSIS CORRECTION. IT IS DETECTED IMMEDIATELY AFTER SURGERY THROUGH XRAY EXAMINATION. THE SUTURED WOUND IS REOPENED AND THE SMALL PIECE EXTRACTED. THERE IS NO CLNICAL CAUSE FOR THIS EVENT. NO CLINICAL CONSEQUENCE SHOULD BE EXPECTED AS THE PARTICLE HAS BEEN PROMPTLY REMOVED; THE ONLY REMAINING CLINICAL DAMAGE IS THE REOPENING OF THE WOUND.

    Description of Event or Problem · 1

    AFTER SURGERY IT WAS NOTICED THAT THE INSTRUMENT TIP PLATE WAS BROKEN AND LEFT IN THE PATIENT. THE SURGEON REMOVED THE SAME DAY THE INSTRUMENT PART FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760118 PEDICLE SCREW LOCKING TOWER ENH 2019 SURGICAL INSTRUMENT FOR SPINE SURGERY LXH MEDACTA INTERNATIONAL SA 2052849 07630971256538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention