BEUDAMED
    FDA Adverse Event Other Summary report: N

    MANTIS ROD INSERTER SHAFT

    MDR report key: 1373764 · Received May 1, 2009

    Report

    Report Number
    9617544-2009-00135
    Event Type
    Other
    Date Received
    May 1, 2009
    Date of Event
    September 15, 2008
    Report Date
    September 16, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    9617544-4/27/09/001R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS BEEN COMPLETED AND EVAL CODES UPDATED. - METHOD - VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, TECHNICAL/MEDICAL ASSESSMENT. RESULTS - VISUAL INSPECTION - CONFIRMED THE REPORTED FAILURE. COMPLAINT HISTORY REVIEW - TO DATE THE RETURN RATE FOR THIS INSTRUMENT IS APPROXIMATELY 8.5% OF THE INSTRUMENTS DISTRIBUTED. TECHNICAL/MEDICAL ASSESSMENT - TWO POTENTIAL HARMS WERE IDENTIFIED IN THE MODERATE OR SERIOUS ZONE. POTENTIAL REVISION SURGERY AND ADVERSE REACTION FROM THE METAL REQUIRING MEDICAL INTERVENTION WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE INNER SHAFT DOESN'T HOLD THE ROD OR ROTATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS ROD INSERTER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 078935

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other