BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXTORQUE ZP

    MDR report key: 1397190 · Received May 29, 2009

    Report

    Report Number
    3005039508-2009-00009
    Event Type
    Injury
    Date Received
    May 29, 2009
    Date of Event
    May 4, 2009
    Report Date
    May 4, 2009
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K082574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE SALES DISTRIBUTOR THAT THE HOSPITAL WAS PERFORMING AN INVESTIGATION. WE CONTACTED THE HOSPITAL INVESTIGATOR, WHO FINISHED HER INVESTIGATION, WHICH WAS INCONCLUSIVE; HOWEVER, SHE DID STATE THAT OUR SURGICAL TRAY WAS CLEARED TO BE USED IN THE HOSPITAL AGAIN. IT WAS ALSO REPORTED THAT THIS TRAY HAS ALSO BEEN USED IN OTHER FACILITIES WITHOUT ANY REPORTED ADVERSE EVENTS.

    Description of Event or Problem · 1

    THE SALES DISTRIBUTOR REPORTED THAT AT SURGERY CENTER, THREE CASES OF INFECTIONS WERE REPORTED AFTER THE USE OF TRAY IAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXTORQUE ZP MINI MAXTORQUE CANNULATED SCREWS HWC ORTHOHELIX SURGICAL DESIGNS, INC. SURGICAL TRAY IAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention