BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP PLATE SCREWS

    MDR report key: 4031512 · Received August 22, 2014

    Report

    Report Number
    0002249697-2014-03243
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K943549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED 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 NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A BROKEN GAP SCREW THAT WAS FIX IN THE PELVIS THROUGH A TRITANIUM CUP. CUP, SCREWS, LINER, AND 36 HEAD WERE EXPLANTED, THEN REPLACED WITH TRITANIUM CUP, SCREWS, AND MDM.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A BROKEN GAP SCREW THAT WAS FIX IN THE PELVIS THROUGH A TRITANIUM CUP. CUP, SCREWS, LINER, AND 36 HEAD WERE EXPLANTED, THEN REPLACED WITH TRITANIUM CUP, SCREWS, AND MDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509217 GAP PLATE SCREWS IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MHJPAX

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention