BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUNTER PASSIVE TENDON IMPLANT

    MDR report key: 5900325 · Received August 24, 2016

    Report

    Report Number
    1043534-2016-00086
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    August 3, 2016
    Report Date
    August 24, 2016
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS CONSIDERED CLOSED. IF AT ANY TIME NEW OR UPDATED INFORMATION BECOMES AVAILABLE, THE INCIDENT WILL BE RE-OPENED AND INVESTIGATED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE REP WAS CONTACTED BY FACILITY TO BILL FOR ROD. REP BILLED. ONCE CSR TRIED TO BILL WE COULD NOT LOCATE LOT. AFTER RESEARCH CONFIRMED IT WAS EXPIRED. ISSUE NOT RESOLVED PER INCIDENT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552551 HUNTER PASSIVE TENDON IMPLANT SMALL JOINT COMPONENT HXR WRIGHT MEDICAL TECHNOLOGY, INC. 058605727

    Patients

    Seq Age Sex Outcome Treatment
    1