BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE OSTIUM PUNCH

    MDR report key: 338028 · Received June 7, 2001

    Report

    Report Number
    338028
    Event Type
    Malfunction
    Date Received
    June 7, 2001
    Date of Event
    March 15, 2001
    Report Date
    April 26, 2001
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KTF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A METAL FRAGMENT BROKE OFF OF A ROTATABLE OSTIUM PUNCH DURING SINUS SURGERY. THE PIECE WAS RETRIEVED BY THE SURGEON WITH NO PT PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26236 ROTATABLE OSTIUM PUNCH OSTIUM PUNCH KTF RICHARD WOLF GMBH 8211.661 P654487

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR