BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD TRAID SKULL CLAMP

    MDR report key: 3893609 · Received June 9, 2014

    Report

    Report Number
    3004608878-2014-00082
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    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

    THIS IS THE THIRD REPORT INVOLVING AN A1108 FROM THE SAME FACILITY. THE SAME PROBLEM OCCURRED THREE TIMES WITH THREE DIFFERENT EXPERIENCED SURGEONS. THE FIRST REPORT OCCURRED IN (B)(6) 2014 AND WAS SUBMITTED ON (B)(6) 2014 UNDER MFR REPORT #3004608878-2014-00020 (B)(4). IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A CRANIOTOMY UTILIZING AN A1108. THE PATIENT'S HEAD "DROPPED" A FEW MINUTES AFTER FIXING IT IN THE SKULL CLAMP. THE PATIENT INCURRED A SMALL SCRATCH WHICH DID NOT REQUIRE ANY SUTURING. THE PATIENT RECOVERED FROM THE INJURY. THE SURGERY WAS DELAYED 15 MINUTES. REUSABLE SKULL PINS WERE USED DURING THIS PROCEDURE. A STEREOTAXY DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335000 MAYFIELD TRAID SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other