BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 8678450 · Received June 7, 2019

    Report

    Report Number
    8678450
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 29, 2019
    Report Date
    May 30, 2019
    Manufacturer
    DEGEN MEDICAL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TIP OF DEGEN BONE TAP BROKE OFF WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472238 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEGEN MEDICAL 97-55G 15564L02

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA