BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10 DEG X3 INSERT 36MM ID

    MDR report key: 2850821 · Received November 21, 2012

    Report

    Report Number
    2249697-2012-02442
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS/LOTS CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 502-03-58F, LOT # MJR8NM, DESCRIPTION: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58 MM; CAT # 2030-6516-1, LOT # MHR6AJ, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 16 MM; CAT # 2030-6540-1, LOT # MHKHA8, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 40 MM; CAT # 18-36-3, LOT # 30777401, DESCRIPTION: DELTA C-TAPER HEAD 36 MM -2.5. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. THE SALES REP CONFIRMED THAT THE HOSPITAL WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION. A REVIEW OF THE DHR INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOTS. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOTS. INSUFFICIENT INFORMATION WAS RECEIVED TO CONFIRM THE REPORTED EVENT OR DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 DEG X3 INSERT 36MM ID IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MJPXML

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R