BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON-TYPE BALL DISS 90D 71/2 TT

    MDR report key: 2584474 · Received May 21, 2012

    Report

    Report Number
    2523190-2012-00050
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    INTEGRA YORK PA INC
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. CUSTOMER REPORTS THEY ARE WAITING FOR FDA APPROVAL TO RETURN DEVICE TO MFR.

    Description of Event or Problem · 1

    TIP BROKE OFF IN PT. AFTER DOING X-RAYS, THEY COULDN'T LOCATE IT AND BELIEVE THAT TIP WAS SUCTIONED UP. THE HOSP IS DOING THEIR RISK ANALYSIS. RMA (B)(4) WAS PROVIDED BUT INSTRUMENT MAY NOT BE RETURNED. CUSTOMER IS REQUESTED A REPLACEMENT. ON (B)(6) 2012 MESSAGE LEFT (SLEE). ON (B)(6) 2012 CUSTOMER REPORTS THE DEVICE WAS BEING USED DURING A MICRODISKECTOMY (AS IN OPEN LAMINECTOMY). THE DR WAS PROBING THE AREA, USING THE INSTRUMENT AS INTENDED WHEN IT BROKE. THERE WAS NOT PT INJURY. THE PT WILL BE X-RAYED WHEN THEY HAVE THEIR RETURN VISIT. THE CUSTOMER SAYS THE DEVICE WILL BE RETURNED ONCE THE FDA SAYS THEY CAN DO SO (SLEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHOTON-TYPE BALL DISS 90D 71/2 TT NA GZX INTEGRA YORK PA INC

    Patients

    Seq Age Sex Outcome Treatment
    1