BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 1880679 · Received October 25, 2010

    Report

    Report Number
    1043534-2010-00421
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 8, 2010
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K051348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED BY THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.EVIDENCE THAT PRODUCT IN SPEC WHEN USED.USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT. ALLEGEDLY THE PATIENT (ER NURSE) WAS HOLDING A PATIENT DURING A LUMBAR PUNCTURE IN THE ER WHEN THE EVENT OCCURRED.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT. ALLEGEDLY THE PATIENT (ER NURSE) WAS HOLDING A PATIENT DURING A LUMBAR PUNCTURE IN THE ER WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 046334280

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R