BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICASSO II PEDICLE SCREW SYSTEM

    MDR report key: 20848619 · Received December 4, 2024

    Report

    Report Number
    3009051471-2018-00040
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    April 4, 2018
    Report Date
    December 4, 2024
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    HWX
    PMA / PMN Number
    K140219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CTL AMEDICA IS IN THE PROCESS OF REVIEWING POTENTIAL MDR'S FROM PREVIOUS YEARS, AS PART OF DUE DILIGENCE TO STAY IN COMPLIANCE. THIS INCIDENT FROM 2018 WAS NOT SUBMITTED AS AN MDR, BUT AFTER REVIEW IT WAS DECIDED THAT IT SHOULD BE SUBMITTED. THEREFORE, THIS REPORT IS BEING SUBMITTED ON (B)(6)2024 RETROACTIVELY FOR THE INCIDENT IN 2018. THERE HAS BEEN NO REPORTS OF PATIENT PAIN OR COMPLICATIONS FROM THIS INCIDENT IN 2018.

    Description of Event or Problem · 0

    PEDICLE SCREW TAPS (6.5 DIAMETER) WERE DISCOVERED POST-OP IN CLEANING TO BE BROKEN (QUANTITY: (B)(4)). POST-OP X-RAYS DO NOT SHOW ANY FRAGMENTS OF THE TAPS IN THE PATIENT, AND IT IS UNCLEAR IF THE TAPS BROKE DURING SURGERY OR DURING POST-OP CLEANING. NO ISSUES WITH THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228047 PICASSO II PEDICLE SCREW SYSTEM TAP HWX CTL MEDICAL CORPORATION 119.7038 7HJBC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown