BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROC XS FASTENER

    MDR report key: 139030 · Received December 17, 1997

    Report

    Report Number
    1222933-1997-00005
    Event Type
    Injury
    Date Received
    December 17, 1997
    Date of Event
    November 20, 1997
    Report Date
    December 17, 1997
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR REPORTED THAT ELEVEN WEEKS POST-OPERATIVELY, THE PT FELL OFF A SCAFFOLD. HE SCOPED THE PT'S SHOULDER AND FOUND THAT TWO OF THE THREE ANCHORS HE HAD INITIALLY PLACED WERE PULLED ABOVE THE BONE SURFACE. HE OPENED THE SHOULDER, AND REMOVED THE TWO ANCHORS. HE REPLACED ONE ANCHOR WITH ANOTHER INNOVASIVE ROC XS FASTENER, AND THEN PERFORMED TWO BONE TUNNELS. THE DR REPORTED THAT THERE WAS HEALING AROUND THE TWO ANCHORS HE REMOVED, AND THAT THE SUTURE HAD NOT BROKEN. HE ALSO REPORTED THAT THE WINGS OF THE DEVICE WERE OPEN. THIS INDICATES THE DEVICES HAD FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROC XS FASTENER Implant BONE ANCHOR MBI INNOVASIVE DEVICES, INC. NA 10545

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention