BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    MDR report key: 20308719 · Received September 26, 2024

    Report

    Report Number
    3005180920-2024-00779
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630040716086
    PMA / PMN Number
    K171758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2024. LOT 2459779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUNE-2024. EXPIRATION DATE: 2029-05-30. 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. BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2024 ON THE OTHER COMPONENT INVOLVED IN THE EVENT: MECTALIF TRANSFORAMINAL (TI PEEK) 03.23.151 TRANSFORAMINAL INTERBODY FUSION DEVICE TIPEEK 12X30X8 L5° (K200551) LOT 2120811: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2021. EXPIRATION DATE: 2026-07-22. 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. CLINICAL EVALUATION. A REVISION SURGERY WAS PERFORMED A FEW DAYS AFTER AN L3-L4 STABILIZATION PROCEDURE. THE REPORTED REASON FOR THE REVISION WAS LOOSENING OF ONE SET SCREW AND THE TLIF CAGE. THE PATIENT EXPERIENCED A FALL DURING REHABILITATION, AND A RADIOLOGICAL FOLLOW-UP REVEALED THE FAILURE. FROM THE AVAILABLE X-RAY AND CT IMAGES, IT IS EVIDENT THAT ONE SET SCREW ON L4 WAS NOT FULLY SEATED AND APPEARED TILTED, WHILE THE CAGE WAS MISALIGNED, SHOWING LATERALIZATION AND ROTATION. THE SURGEON SUSPECTED THAT THE SET SCREW MAY HAVE BEEN IMPROPERLY TILTED FROM THE BEGINNING, UNABLE TO BE FULLY TIGHTENED INTO ITS POSITION. THIS COULD HAVE LED TO SOME DEGREE OF INSTABILITY IN THE CONSTRUCT, POTENTIALLY WORSENED BY THE PATIENT'S FALL, WHICH ALSO RESULTED IN CAGE DISPLACEMENT. THERE IS NO INDICATION TO SUGGEST A DEFECTIVE OR MALFUNCTIONING DEVICE, ALSO CONSIDERING THAT THE PICTURE OF THE SUBJECTED DEVICE DID NOT REVEAL SIGNS OF DAMAGE. PICTURES ANALYSIS: THE TLIF CAGE 03.23.151, LOT NO. 2120811, SHOWS NO SIGNS OF DAMAGES FROM THE PICTURES RECEIVED. CONSIDERING THE DESCRIPTION OF THE EVENT THE ROOT CAUSE OF THE COMPLAINT COULD BE THE LOOSENING OF ONE SETSCREW THAT LED TO AN INSTABILITY OF THE CONSTRUCT.

    Description of Event or Problem · 0

    A REVISION SURGERY WAS PERFORMED A FEW DAYS AFTER AN L3-L4 STABILIZATION PROCEDURE. THE REPORTED REASON FOR THE REVISION WAS LOOSENING OF ONE SET SCREW AND THE TLIF CAGE. THE PATIENT EXPERIENCED A FALL DURING REHABILITATION, AND A RADIOLOGICAL FOLLOW-UP REVEALED THE FAILURE. SETSCREW AND CAGE WERE SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238959 PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X) SPINE SET SCREW PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 2459779 07630040716086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention