BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX35MM

    MDR report key: 3033584 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-14851
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    J & J MEDICAL (DEPUY- SUZHOU)LTD. 3006356043
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    UPDATED: 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS REPORTED THAT THE PATIENT HAD FALLEN. THE CUP WAS FOUND TO HAVE MOVED FROM ITS CORRECT POSITION AND WAS REPORTED TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136945 PINN CAN BONE SCREW 6.5MMX35MM BONE SCREW NDJ J & J MEDICAL (DEPUY- SUZHOU)LTD. 3006356043 D12090403

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention