BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM ROOF PILE SCREW 35MM

    MDR report key: 3231208 · Received July 17, 2013

    Report

    Report Number
    1818910-2013-21422
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 2, 2010
    Report Date
    June 26, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDJ
    PMA / PMN Number
    PK962007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. FROM A MEDICAL PERSPECTIVE, BASED ON THE LIMITED INFORMATION AVAILABLE TO BE REVIEWED, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN, LOOSE CAGE AND METALLOSIS. PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331453 TITANIUM ROOF PILE SCREW 35MM BONE SCREW JDJ DEPUY ORTHOPAEDICS INC US Y4AJP4000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention