BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 7515359 · Received May 15, 2018

    Report

    Report Number
    1722511-2018-00017
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 19, 2018
    Manufacturer
    ORTHO DEVELOPMENT
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS UNKNOWN BY THE REPORTER. PRODUCT IS CLASS I EXEMPT. NO 510(K).

    Description of Event or Problem · 1

    AN INTRAOPERATIVE FRACTURE OCCURRED DURING REAMING FOR A HIP STEM. THE SURGEON USED CEMENT TO FIX THE FRACTURE. THE REPORT INDICATED THE FRACTURE WAS UNRELATED TO ANY PRODUCT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356895 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ORTHO DEVELOPMENT 201-2405

    Patients

    Seq Age Sex Outcome Treatment
    1