BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MUST STRAIGHT CROSS CONNECTOR 20MM

    MDR report key: 9069328 · Received September 16, 2019

    Report

    Report Number
    3005180920-2019-00783
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630040705844
    PMA / PMN Number
    K171170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 AUGUST 2019. LOT 1821436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2018. EXPIRATION DATE: 01-11-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 1 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    SPINAL FIXATION PERFORMED AT T4-T8. THE SURGEON HAD A PLAN TO SET 3 CONNECTORS. THE SURGEON WAS NOT ABLE TO SET THE MUST STRAIGHT CROSS CONNECTOR AT T4-T5 BECAUSE BOTH HOOKS OF THE MUST STRAIGHT CROSS CONNECTOR CONTACTED TO THE FACET JOINT. OTHER 2 CONNECTORS WERE USED FOR OTHER INTERVERTEBRAL LEVEL. THEY CONTACTED TO THE FACET JOINT TOO, BUT THE SURGEON WAS ABLE TO SET THE MUST STRAIGHT CROSS CONNECTOR. 10 MINUTES OF DELAY REPORTED. TOTAL SURGERY TIME ABOUT 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867994 PEDICLE SCREW MUST STRAIGHT CROSS CONNECTOR 20MM CROSS CONNECTOR KWP MEDACTA INTERNATIONAL SA 1821436 07630040705844

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other