BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 3595399 · Received January 28, 2014

    Report

    Report Number
    2520274-2014-00331
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES MNI AND KWP. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A POSTER DECOMPRESSION FUSION BETWEEN T10- SACRUM 1. AT THE END OF THE PROCEDURE WHEN THE SURGEON TORQUED THE LOCKING NUTS ON THE USS SCREW, THE COLLAR GROOVES BROKE. THE SURGEON REPLACED THE COLLAR GROOVES AND WAS ABLE TO COMPLETE PROCEDURE SUCCESSFULLY. THE EVENT DELAYED THE PROCEDURE BY 10-15 MINUTES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60598 TI COLLAR WITH GROOVES MNH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1