BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO

    MDR report key: 3792307 · Received May 15, 2012

    Report

    Report Number
    3792307
    Event Type
    Malfunction
    Date Received
    May 15, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 15, 2012
    Manufacturer
    UNK
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE DEPUY TANGO INSERTER SCREWDRIVER BROKE OFF IN THE SCREW AT THE S1 (LEFT) LEVEL. THE SCREW WAS LEFT IN. THE DOCTOR PROCEEDED TO THE RIGHT SIDE USING ANOTHER TANGO SCREW DRIVER AND THAT TIP BROKE OFF IN THE SCREW. WHEN TRYING TO REMOVE THE SCREW AT L3 (RIGHT), THE HEAD OF THE SCREW BROKE OFF AND IT WAS LEFT IN THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANGO SCREWDRIVER HXX UNK CS3027 *
    2 TANGO SCREW SCREW HWC UNK CS283-21 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *