BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI

    MDR report key: 5913359 · Received August 25, 2016

    Report

    Report Number
    MW5064420
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    August 11, 2016
    Report Date
    August 25, 2016
    Manufacturer
    DEPUY
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (B)(6) FEMALE WITH A HISTORY OF PROGRESSIVELY WORSENING CHRONIC LOWER BACK AND LEFT LOWER EXTREMITY PAIN WAS ADMITTED TO EUHM ON (B)(6) 2016. SHE HAD SURGERY ON (B)(6) 2016. DURING THE PROCEDURE, THE JASHIDI DEVICE FAILED AND LEFT A RETAINED FRAGMENT. A POSTOPERATIVE CT OF THE ABDOMEN SHOWED A FRACTURED SCREW WITHIN THE ANTERIOR L4 BODY NEAR THE LEFT COMMON ILIAC ARTERY AND COMMON ILIAC VEIN. DUE TO THE ANTERIOR POSITIONING OF THE SCREW IT COULD NOT BE RETRIEVED AT THAT TIME. SHE WAS RETURNED TO SURGERY THE NEXT DAY FOR THE SCREW REMOVAL. IT WAS SUCCESSFULLY REMOVED WITH ASSISTANCE FROM VASCULAR SURGERY. THE PT HAD NO FURTHER INCIDENTS FROM THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2016 TO AN ACUTE REHAB CENTER. PROCODE CODE; (B)(4) PRODUCT DESCRIPTION: INTRODUCER NEEDLE, DIAMOND TIP, 11G 6" GTN (B)(4) LEGAL MFR (UDI LABELER): DEPUY SPINE INC. / (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554695 JAMSHIDI JAMSHIDI FCG DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R