BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTIS CANNULATED MODULAR TAP 5.5MM

    MDR report key: 2230823 · Received August 23, 2011

    Report

    Report Number
    9617544-2011-00290
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, MANUFACTURING RECORD REVIEW, RISK ASSESSMENT AND VISUAL INSPECTION. RESULTS: COMPLAINT HISTORY ANALYSIS. FORTY EIGHT COMPLAINTS INVOLVING 68 INSTRUMENTS. MANUFACTURE RECORD REVIEW. NO DEVIATIONS NOTED. RISK ASSESSMENT. TIP REMAINS IN PT'S SACRUM. TAP IS MADE OF A BIOCOMPATIBLE STEEL TO MITIGATE ANY RISKS IF LEFT IN THE PT. WORST CASE SCENARIO IS IF THE PT HAS A METAL ALLERGY, WHICH IS NOT INDICATED FOR THIS CASE. VISUAL INSPECTION. TIP CONFIRMED BROKEN. TIP NOT RETURNED. ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PIECES OF MANTIS CANNULATED 5.5MM TAP BROKE OFF IN PTS SACRUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED MODULAR TAP 5.5MM INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 08A085

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR