BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMA

    MDR report key: 2982927 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-01218
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SYNTHES
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CORNER MISSING FROM TRIAL SPACER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, A CORNER WAS MISSING FROM A TRIAL SPACER. THE SURGEON REPORTED THAT THE DILATORS WERE AUTO ROTATING WHICH ADDED EXTRA TIME TO THE PROCEDURE. THE SURGEON MENTIONED THAT THERE WAS MORE RADIOLUCENCY IN THE NEW DILATORS. ALSO, THE SURGEON REPORTED THAT THE STABILITY ARM WAS ATTACHED INCORRECTLY TO THE RETRACTOR. THE T-HANDLE STUCK TO THE ORACLE TRIALS WHICH CAUSED TIME DELAY WITH THE PROCEDURE. THE TIME DELAY OF THE SURGERY IS UNKNOWN. THIS REPORT IS FOR UNKNOWN TRIAL SPACER. THIS IS REPORT NUMBER 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86794 TRAUMA MQP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR