BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL

    MDR report key: 11819628 · Received May 13, 2021

    Report

    Report Number
    1644408-2018-00375
    Event Type
    Injury
    Date Received
    May 13, 2021
    Report Date
    December 2, 2020
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ORIGINAL INITIAL REPORT WAS SUBMITTED AS FOLLOW UP IN ERROR.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO A LOOSE GLENOID WITH BROKEN CENTRAL SCREW BEING REMOVED. THE REASON FOR BREAK/ LOOSENING IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714847 GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL PHX 869C2132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R