BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCHR POST/HOOP SCREW

    MDR report key: 2002279 · Received January 25, 2011

    Report

    Report Number
    1222895-2011-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    INTEGRA RADIONICS, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO PLACE (B)(6) ON THE PT'S HEAD USING THE (B)(6) POSTS. THREE OF THE (B)(6) POSTS WERE SCREWED INTO THE PT'S HEAD. WHILE TIGHTENING THE HEAD POST ATTACHMENT SCREW ON THE LAST ANTERIOR POST, THE SCREW THAT ATTACHES TO THE LOWER PART OF THE POST TO THE (B)(6) 'SHEARED OFF AT THE HEAD." BECAUSE THE SCREW BROKE OFF, THE PHYSICIAN WAS NOT ABLE TO ATTACH THE FOURTH POST. THERE WERE NO BACKUP SCREWS AVAILABLE. THE THREE OTHER POSTS FIXED TO THE PT'S HEAD HAD TO BE REMOVED. BANDAIDS WERE PLACED ON THE PT'S HEAD WHERE THE SCREWS WERE REMOVED. NO PT INJURY WAS REPORTED. THE CASE WAS CANCELED AND RESCHEDULED. THE BIOPSY DID TAKE AT A LATER DATE WITHOUT USING A FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCHR POST/HOOP SCREW NA HAW INTEGRA RADIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR