BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA 360 PATIENT POSITIONING SYSTEM

    MDR report key: 4180712 · Received October 15, 2014

    Report

    Report Number
    3004608878-2014-00190
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DURING PRE-SURGERY PREPARATION ON (B)(6) 2014, THE LOWER HANDLE ROD BROKE. THIS EVENT DID NOT INVOLVE A PATIENT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2014 FROM THE DISTRIBUTOR: DATE OF EVENT: (B)(6) 2014. THIS EVENT DIDN'T INVOLVE PATIENTS. THIS OCCURRED BEFORE THE SURGERY, SO NO DELAY OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654683 ULTRA 360 PATIENT POSITIONING SYSTEM BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA 117

    Patients

    Seq Age Sex Outcome Treatment
    1