BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP LOANER

    MDR report key: 4898265 · Received July 6, 2015

    Report

    Report Number
    3004608878-2015-00186
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 15, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 8/7/2015. THE INVESTIGATION INCLUDED: METHOD: DHR REVIEW. REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. VISUAL INSPECTION. RESULTS: THIS DEVICE WAS MANUFACTURED ON DECEMBER 31, 2009 AND A REVIEW OF DHRS CONTAINING LOT CODE 099 SHOWED THAT THIS LOT PASSED THE REQUIRED INSPECTION POINTS WITHOUT MRRS, REWORKS OR VARIANCES. SERVICE HISTORY: DATE OF SERVICE: 05/16/2015 RGA#: (B)(4). DATE OF SERVICE: 12/09/2014 RGA#: (B)(4). DATE OF SERVICE: 06/23/2014 RGA#: (B)(4). DATE OF SERVICE: 12/23/2013 RGA#: (B)(4). DATE OF SERVICE: 10/08/2013 RGA#: (B)(4). DATE OF SERVICE: 04/09/2013 RGA#: (B)(4). DATE OF SERVICE: 12/26/2012 RGA#: (B)(4). DATE OF SERVICE: 11/06/2012 RGA#: (B)(4). DATE OF SERVICE: 06/07/2012 RGA#: (B)(4). DATE OF SERVICE: 04/10/2012 RGA#: (B)(4). DATE OF SERVICE: 10/18/2011 RGA# (B)(4). DATE OF SERVICE: 06/10/2011 RGA#: (B)(4). DATE OF SERVICE: 03/18/2011 RGA#: (B)(4). DATE OF SERVICE: 01/13/2011 RGA#: (B)(4). DATE OF SERVICE: 11/12/2010 RGA#: (B)(4). DATE OF SERVICE: 06/08/2010 RGA#: (B)(4). DATE OF SERVICE: 04/08/2010 RGA#: (B)(4). A TWO YEAR LOOK BACK FOR THIS REPORTED FAILURE AND OR RELATED TO "DID NOT LOCK " FOR THIS PRODUCT ID SHOWS THAT (B)(4) WERE RECEIVED INCLUDING THIS CASE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THE LOANER DEVICE INVOLVED IN THIS CASE WAS SENT IN AND WAS NOT EVALUATED SPECIFICALLY FOR SLIPPAGE AS THIS ISSUE WAS NOT COMMUNICATED TO BE THE REASON FOR RETURN UPON THE RECEIPT OF THIS DEVICE. HOWEVER, THIS DEVICE WAS INSPECTED UP AGAINST THE REQUIRED INSPECTION CRITERIA AND PASSED. NO ROOT CAUSE TO THE END USERS EXPERIENCE CAN BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOANER CLAMP WOULD NOT LOCK DOWN WITHOUT SLIPPAGE. THERE WAS NOT ANY PATIENT INVOLVEMENT WITH THIS ISSUE. THE STAFF DISCOVERED THIS DURING SET UP FOR CASE AND HAD TO SCREW THE END BOLT FOR ADJUSTMENT MORE THAN USUAL AND IT WOULD NOT TIGHTEN UP FOR SAFE USAGE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED ON (B)(6) 2015: DATE OF INCIDENT WAS (B)(6) 2015. PATIENT WAS NOT PRESENT IN THE OPERATING ROOM WHEN THE EVENT OCCURRED. THERE WAS A REPLACEMENT PRODUCT AVAILABLE TO BE USED FOR THE SURGERY. THERE WAS NO SURGERY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436386 MAYFIELD MODIFIED SKULL CLAMP LOANER N/A HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1