BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANGORS

    MDR report key: 3205157 · Received June 28, 2013

    Report

    Report Number
    9612420-2013-00007
    Event Type
    Other
    Date Received
    June 28, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKB
    PMA / PMN Number
    K052385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ULRICH MEDICAL HAS IDENTIFIED A LABELING ISSUE ON PART NUMBER CS 3008-045, 6.0 MM DIAMETER - 45 MM TITANIUM ROD FOR THE TANGO RS SCREW AND ROD SYSTEM. SEVERAL LOTS WERE LASER MARKED AS CS 3008-040 (6.0 MM DIAMETER, 40 MM LENGTH) ON THE ROD WITH A LENGTH OF 45 MM. THERE IS NO RISK TO THE PATIENT, AS THE SURGEON WILL MEASURE THE NEEDED LENGTH OF THE ROD INSITU WITH A SEPARATE INSTRUMENT. THE INSTRUMENT IS THEN TRANSFERRED TO THE TRAY TO DETERMINE THE APPROPRIATE LENGTH OF THE ROD. LASER MAKING PART NUMBERS ON THE ROD ARE NOT CONFIRMED BY THE SURGEON BUT THE LENGTH OF THE ROD PER THE MEASURING TOOL. THE ISSUE WAS IDENTIFIED DURING INCOMING GOODS INSPECTION BY ONE OF ULRICH MEDICAL'S CUSTOMERS. (B)(4). ULRICH MEDICAL WILL INFORM ALL OTHER INTERNATIONAL CUSTOMERS OF AFFECTED LOTS AND HAVE THEM IMMEDIATELY QUARANTINED. UNITS WILL BE SHIPPED BACK TO ULRICH MEDICAL AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295835 TANGORS TANGORS ROD, BLUE, 0 6, 0 MM, LENGTH 45 MM NKB ULRICH GMBH & CO. KG CS 3008-045 WSA14719871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA