BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIQUOT SYRINGE DELIVERY SYSTEM

    MDR report key: 2234104 · Received August 29, 2011

    Report

    Report Number
    2530131-2011-00004
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    KIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS CURRENTLY UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION. EVAL: METHOD - ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. BATCH RECORD REVIEW PERFORMED. NO RELEVANT NON-CONFORMANCES NOTED. CATHETER MET ALL SPECS. RESULTS - CATHETER. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PHYSICIAN WAS PERFORMING A VERTEBROPLASTY USING AN ALIQUOT DELIVERY SYSTEM WHEN CATHETER BROKE OFF INSIDE THE NEEDLE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE OF THE CATHETER AND THE PT HAD NO KNOWN ILL EFFECTS FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIQUOT SYRINGE DELIVERY SYSTEM DISPENSER, CEMENT KIH ORTHOVITA, INC. 2090-0501 Q1006002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other