BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 916008 · Received September 20, 2007

    Report

    Report Number
    3004608878-2007-00023
    Event Type
    Injury
    Date Received
    September 20, 2007
    Report Date
    September 20, 2007
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED IN 2007 THAT THE PT NECK WAS BEING FLEXED FOR POSTERIOR CERVICAL FUSION WHEN THE PINS SLIPPED. THE HEAD WAS IN THE SURGEONS HANDS, SO THERE WAS LIMITED CONSEQUENCES. THE PT INCURRED AN APPROXIMATE 5CM LACERATION WHICH WAS CLOSED BY STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMP HBL INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention