BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM

    MDR report key: 18228801 · Received November 29, 2023

    Report

    Report Number
    3012966183-2023-00027
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Report Date
    November 29, 2023
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00819917027495
    PMA / PMN Number
    K133842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW DEMONSTRATED NO NON-CONFORMANCES OR CAPAS RELATED TO THE LOT AS THE LOT MET SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND THE FRAGMENTS REMAINED IN THE PATIENT ARE FROM ANOTHER DEVICE NOT MADE BY TYBER MEDICAL.

    Description of Event or Problem · 0

    THE PATIENT DID NOT DEVELOP A SURGICAL SITE INFECTION. HE HAD SOME DELAYED WOUND HEALING RELATED TO THAT TWO CCHS IMPLANTS WERE IMPLANTED, RECEIVED ON THROUGH (B)(4).DR (B)(6) STATED THAT THE PATIENT WAS CURRENTLY HAPPY AND WOULD SEE HIM AGAIN IN 4 WEEKS. IF REVISION SURGERY IS HAPPY, DR (B)(6) WILL REMOVE DRILL FRAGMENT AT THAT TIME. IF NOT, HE HAS STATED THAT HE WILL LEAVE IT WHERE IT IS. X-RAY REVEALED: SCREW HAS MIGRATED SLIGHTLY AND DRILL BIT FRAGMENT IDENTIFIED. THE FRAGMENTS GENERATED ARE FROM AN UNKNOWN DRILL DEVICE NOT MADE AT TYBER MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79455 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM SCREWS HWC TYBER MEDICAL 04.333.226TS 224165 00819917027495

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other