BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5X20MM PERIPHERAL SCREW, LOCKING

    MDR report key: 10074685 · Received May 20, 2020

    Report

    Report Number
    1220246-2020-01845
    Event Type
    Injury
    Date Received
    May 20, 2020
    Date of Event
    April 24, 2020
    Report Date
    May 20, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296824
    PMA / PMN Number
    K173900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    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 PATIENT HAD AN INITIAL REVERSE SHOULDER PROCEDURE WITH MODIFIED GLENOID SYSTEM IN (B)(6) 2019. THE PATIENT HAD RECENTLY UNDERGONE A REVISION PROCEDURE ON (B)(6) 2020 DUE TO PAIN AND CONSTRUCT DISLOCATION. AT THE (B)(6) REVISION, THE HUMERAL INSERT WAS EXPLANTED AND A SPACER AND NEW INSERT WERE IMPLANTED. THE (B)(6) 2020 REVISION WAS REPORTED UNDER CASE (B)(4). ON (B)(6) 2020, THE PATIENT HAD A THIRD PROCEDURE DUE TO NEUROPATHY; THE FOLLOWING DEVICES WERE ALL EXPLANTED: IMPLANTS: AR-9503S-03C (LOT 19.00210), AR-9555-06 (LOT 16.01037), AR-9564-2436-LAT (LOT 19.00689) AND AR-9560-24 (LOT 02191932) AND 4 SCREWS: AR-9563-16, AR-9563-28 (QTY2) AND AR-9563-20 TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING DEVICES: AR-9502-36ARCA (LOT 18.00755) AND AR-9550-19 RCA (LOT 10071328).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537528 5.5X20MM PERIPHERAL SCREW, LOCKING SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. 5.5X20MM PERIPHERAL SCREW, LOCKING 00888867296824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other