BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLF TAPPING ROOF PILE SCRW20MM

    MDR report key: 3231086 · Received July 17, 2013

    Report

    Report Number
    1818910-2013-21403
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    October 8, 2012
    Report Date
    June 21, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDJ
    PMA / PMN Number
    PK962007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING. UPDATE: (B)(6) 2013 - ADDITIONAL INFORMATION WAS RECEIVED STATING ALL COMPONENTS WERE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332352 SLF TAPPING ROOF PILE SCRW20MM SCREW JDJ 1818910 DEPUY ORTHOPAEDICS, INC. D5LDH1000

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention