BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIQUOT SYRINGE DELIVERY SYSTEM

    MDR report key: 2210082 · Received August 3, 2011

    Report

    Report Number
    2530131-2011-00002
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    March 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    OAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED BY STRYKER SOUTH PACIFIC ON (B)(4) 2011, BUT THE EVENT OCCURRED IN (B)(4) 2011. THIS IS THE FIRST TIME THAT ORTHOVITA HAS BEEN MADE AWARE OF THIS EVENT. THE PHYSICIAN HAS BEEN CONTACTED, BUT HAS NOT YET OFFERED FURTHER INFO OR MET WITH STRYKER REPRESENTATIVES. METHOD: BATCH RECORD REVIEW PERFORMED. NO RELEVANT NON-CONFORMANCES NOTED. CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PHYSICIAN WAS PERFORMING A VERTEBROPLASTY USING AN ALIQUOT DELIVERY SYSTEM WHEN THE CATHETER OR NEEDLE BROKE DURING REMOVAL. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PT. THE INVESTIGATION IS ONGOING AND F/U REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. THIS EVENT OCCURRED IN (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other