BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLT INSERTER GATOR SQUID INTECH GREEN

    MDR report key: 2752604 · Received September 11, 2012

    Report

    Report Number
    3005739886-2012-00006
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Date of Event
    May 30, 2012
    Report Date
    May 30, 2012
    Manufacturer
    SPINAL USA, INC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROCESS. UPON COMPLETION, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2012, THE VOLT INSERTER GATOR INSTRUMENT BOUND UP. NO SIGNIFICANT DELAY TO THE PROCEDURE OR PT INJURY WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLT INSERTER GATOR SQUID INTECH GREEN VOLT INSERTER GATOR SQUID INTECH GREEN KWQ SPINAL USA, INC 1526501A

    Patients

    Seq Age Sex Outcome Treatment
    1