BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDENBERG TORP HA/PLAST-PORE

    MDR report key: 3133243 · Received May 24, 2013

    Report

    Report Number
    1037007-2013-00006
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ETA
    PMA / PMN Number
    K864443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUSACMI THAT DURING A SURGICAL PROCEDURE WHEN THEY WERE PLACING THE PROSTHESE WITH A MICROFORCEPS, IT BROKE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232464 GOLDENBERG TORP HA/PLAST-PORE GOLDENBERG TORP HA/PLAST-PORE ETA GYRUS ACMI, INC. 140917

    Patients

    Seq Age Sex Outcome Treatment
    1