BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 3728171 · Received April 4, 2014

    Report

    Report Number
    2520274-2014-10554
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 20, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNH
    PMA / PMN Number
    PK951794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.ADDITIONAL NARRATIVE:ADDITIONAL DEVICE PRODUCT CODE: MNH, KWP AND KWQ. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A TITANIUM COLLAR WITH GROOVES BROKE DURING SURGERY. NO DELAY IN SURGERY AND NO PATIENT ADVERSE EVENT WAS REPORTED. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE.THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204809 TI COLLAR WITH GROOVES ORTHOSIS,PEDICLE SPINAL FIXATION MNH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR