BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDPOR PLUS SST EZ - 22MM

    MDR report key: 2308210 · Received September 14, 2011

    Report

    Report Number
    1057129-2011-00029
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 14, 2011
    Manufacturer
    STRYKER CRANIOMAXILLOFACIAL GEORGIA
    Product Code
    HPZ
    PMA / PMN Number
    K021357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PRODUCT HISTORY WAS CONDUCTED AND THERE HAVE BEEN NO REPORTS OF A SIMILAR INCIDENT TO HAVE OCCURRED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON WAS USING THE MEDPOR PLUS SST EZ 22MM SPHERE IMPLANT AND ALTHOUGH THE IMPLANT FIT INTO THE SYRINGE "WITH A LITTLE PUSH," THE SURGEON HAD DIFFICULTY GETTING THE SPHERE IMPLANT OUT OF THE SYRINGE. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON USED A 15 BLADE AND AFTER WORKING ON THE SYRINGE FOR A WHILE, PIERCE THE SYRINGE AND WAS ABLE TO PEEL THE SYRINGE OPEN TO GET THE SPHERE IMPLANT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR PLUS SST EZ - 22MM IMPLANT HPZ STRYKER CRANIOMAXILLOFACIAL GEORGIA NA G004828

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization