BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM RAPID RESORB CONTOURABLEMESH/50X50X0.5MM T

    MDR report key: 2221250 · Received August 17, 2011

    Report

    Report Number
    8030965-2011-00554
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K030069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH RESORBABLE MESH TO CONTAIN BONE GRAFT MATERIAL AND THE SURGEON USED A COMPETITOR'S TITANIUM SCREWS, WHICH IS OFF LABEL USE. SURGEON LATER REMOVED THE MESH IN BOTH LOCATIONS SECONDARY TO DEHISCENCE IN ONE SITE AND A DRAINING FISTULA IN THE ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5MM RAPID RESORB CONTOURABLEMESH/50X50X0.5MM T 1.5MM RAPID RESORB CONTOURABLE MESH JEY SYNTHES GMBH 2658895

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention THK| 1.5MM RAPID RESORB CONTOURABLEMESH/50X50X0.5MM