BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PLST INS IMP TIP 32MM

    MDR report key: 3163128 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01881
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6), REPORTED TO THE SALES REP, (B)(6), THAT AN EMPLOYEE IN SSD CUT HER FINGER ON A FAULTY HEAD PUSHER.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6), REPORTED TO THE SALES REP, (B)(4), THAT AN EMPLOYEE IN (B)(6) CUT HER FINGER ON A FAULTY HEAD PUSHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263417 TRIDENT PLST INS IMP TIP 32MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other