BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD INFINITY SKULL CLAMP

    MDR report key: 3252295 · Received July 25, 2013

    Report

    Report Number
    3004608878-2013-00139
    Event Type
    Injury
    Date Received
    July 25, 2013
    Report Date
    July 25, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE SWIVEL CAME UNLOCKED WHILE ATTACHED DURING PT POSITIONING. ADDITIONAL INFO WAS REQUESTED AND THE FOLLOWING WAS PROVIDED BY THE CUSTOMER ON (B)(6) 2013: THE CUSTOMER STATED THAT SHE DID NOT RECEIVE A REPORT THAT THIS CLAMP CAME UNLOCKED. HOWEVER, THIS MAYFIELD SKULL CLAMP WAS INVOLVED IN A SLIPPAGE AND PT LACERATION. SHE DID NOT HAVE ANY FURTHER DETAILS OR INFO REGARDING THIS INCIDENT OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347162 MAYFIELD INFINITY SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other