BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 03.52.415 ENH. ROD TI 5.5X200MM

    MDR report key: 16831295 · Received April 28, 2023

    Report

    Report Number
    3005180920-2023-00314
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030858086
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-APR-2023; LOT 2121497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUL-2021. EXPIRATION DATE: 2026-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 51 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: ONE YEAR AFTER THORACO-LUMBAR FUSION ON 4 LEVELS ONE OF THE RODS BROKE AND NEEDED EXCHANGING. WE HAVE NO HISTORY OF THE CASE AND THE ONE PICTURE SUPPLIED IS OF EXTREMELY LOW QUALITY, SO THAT IT'S IMPOSSIBLE TO OFFER A THOROUGH RECONSTRUCTION OF THE CASE. IT CAN BE ASSUMED THAT IT ORIGINATED FROM A VERTEBRAL FRACTURE WHICH DID NOT HEAL COMPLETELY AFTER ONE YEAR. IN THESE CONDITIONS, THE TEMPORARY IMPLANTS ARE SUBJECT TO FATIGUE FAILURE. IN THIS CASE, THE NECESSITY OF BRIDGING THE BROKEN VERTEBRA EXPOSED THE ROD TO AN INCREASED STRESS AND, COUPLED WITH THE LACK OF FUSION AT 12 MONTHS, FRACTURE OCCURRED. VISUAL INSPECTION PERFORMED BY R&D MANAGER: AS CAN BE SEEN IN THE X-RAY AND IN PICTURE SENT, THE ROD BROKE. THE CONSTRUCT IS MADE OF 4 SCREWS THAT COVER 5 VERTEBRAE, WITH THE CENTRAL VERTEBRA WITHOUT SCREW. THE CRACKING HAPPENED ADJACENT TO THE TWO UPPER PEDICLE SCREWS, ON THE SIDE FACING THE NOT SUPPORTED AREA. IT IS UNKNOWN IF ANY TRAUMATHIC EVENT THAT MAY HAVE REDUCED THE STRENGTH OF THE IMPLANT OCCURRED. THE ROOT CAUSE MAY HAVE BEEN A LACK BONE FUSION COMBINED WITH THE MISSING SUPPORT OF A SCREW IN THE LEVEL ADJACENT TO THE BREAKAGE PLANE.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 1 YEAR AND 1 MONTH AFTER PRIMARY DUE TO ENH. ROD TI 5.5X200MM BREAKAGE WHILE THE PATIENT WAS SITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477135 PEDICLE SCREW 03.52.415 ENH. ROD TI 5.5X200MM SPINE ENH. ROD TI NKB MEDACTA INTERNATIONAL SA 03.52.415 2121497 07630030858086

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention