BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER TRIAL HEAD 32MM +10

    MDR report key: 2861203 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02159
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 7, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS: MFR # 2249697-2012-02158.

    Description of Event or Problem · 1

    SO CUSTOMS GROUP ADVISED OF A LOCAL PER: SURGEON REQUESTING A SPECIALTY INSTRUMENT TO PREVENT THE C-TAPER HEADS TRIALS FROM DISASSOCIATING FROM THE C-TAPER NECK TRIAL DURING TRIAL REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER TRIAL HEAD 32MM +10 INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other