BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3163133 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01883
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE LOT WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OPENED A LINER AND A BIG BLACK CURLY HAIR WAS INSIDE. OPENED ANOTHER LINER AND COMPLETED CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OPENED A LINER AND A BIG BLACK CURLY HAIR WAS INSIDE. OPENED ANOTHER LINER AND COMPLETED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263875 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMDYRT

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other