BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODIFIED SKULL CLAMP

    MDR report key: 2925133 · Received January 17, 2013

    Report

    Report Number
    3004608878-2013-00007
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 17, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    AN A 1059 MAYFIELD SKULL WAS REPORTED TO HAVE SLIPPED ON A PT WHO WAS POSITIONED PRONE FOR A CRANIOTOMY. IT WAS UNKNOWN WHETHER THE PT WAS REPOSITIONED AT ANY TIME DURING THE SURGERY OR WHAT THE LENGTH OF TIME IN USE WAS BEFORE THE EVENT (S) OCCURRED. THE PT INCURRED A 3 CM LACERATION WHICH REQUIRED CLOSURE. THE PT OUTCOME: SHE WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26566 MODIFIED SKULL CLAMP NA HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR