BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED HOHMANN RETRACTORS ORTHOLUCENT NARROW

    MDR report key: 7929338 · Received October 3, 2018

    Report

    Report Number
    7929338
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    July 20, 2018
    Report Date
    September 27, 2018
    Manufacturer
    INNOMED, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF CARBON FIBER HOHMAN BROKE DURING ANTERIOR APPROACH TOTAL HIP SURGERY. ENTIRE SURGERY WAS DONE UNDER FLOUROSCOPY. NO EVIDENCE OF RETAINED FOREIGN OBJECT IN PATIENT. HOHMAN WAS SEQUESTERED REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772666 MODIFIED HOHMANN RETRACTORS ORTHOLUCENT NARROW RETRACTOR GAD INNOMED, INC. 1216 CSL

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA