BEUDAMED
    FDA Adverse Event Other Summary report: N

    TI-SCREW ANCHOR

    MDR report key: 718151 · Received May 15, 2006

    Report

    Report Number
    1825034-2006-00046
    Event Type
    Other
    Date Received
    May 15, 2006
    Date of Event
    April 13, 2006
    Report Date
    April 20, 2006
    Manufacturer
    ARTHROTEK/BIOMET, INC.
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BANKART LESION REPAIR PROCEDURE, TITANIUM SCREW ANCHOR FRACTURED AND FRAGMENT REAMINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI-SCREW ANCHOR SCREW, ANCHOR HWC ARTHROTEK/BIOMET, INC. NA 800050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other