BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SCREW, 2.4 X 10MM, CORTEX

    MDR report key: 9570004 · Received January 9, 2020

    Report

    Report Number
    1220246-2020-01562
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 4, 2019
    Report Date
    January 9, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867045071
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE NOT LOCKED INTO THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/2019: CASE DATE OF IMPLANTATION: (B)(6) 2019, CASE DATE OF EXPLANTATION: NOT YET DETERMINED. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-10 LOT: 1058931, AR-8724V-10 LOT: W654331, AR-8724V-16 LOT: W630941, AR-8935-12 LOT: 10220124, AR-8935L-12 LOT: 10248943, AR-8935L-12 LOT: 10257929. NOTE: THE SPECIFIC DATE OF THE SECOND SURGERY (EXPLANT) IS UNKNOWN, HOWEVER IT IS KNOWN THAT THE DATE WAS PRIOR TO (B)(6) 2019. FOR REPORTING PURPOSES (B)(6) 2019 HAS BEEN ENTERED AS THE DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33853 LOW PROFILE SCREW, 2.4 X 10MM, CORTEX SCREW, FIXATION, BONE HWC ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 10MM, CORTEX 1058931 00888867045071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other