BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUGGLES LEYLA RETRACTION SYSTEM RIGID HOLDING

    MDR report key: 2427480 · Received January 9, 2012

    Report

    Report Number
    2523190-2012-00003
    Event Type
    Injury
    Date Received
    January 9, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 9, 2012
    Manufacturer
    INTEGRA YORK, PA, INC.
    Product Code
    GZT
    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 NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    "CLAMP BALL JOINT FAILED WHEN HOOKS WERE PLACED CAUSING PATIENT INJURY." ADDITIONAL INFORMATION RECEIVED FROM THE ASSISTANT NURSE MANAGER NOTED THAT DURING A RIGHT SIDED CRANIOTOMY PERFORMED FOR THE RESECTION OF AN ARTERIAL VENOUS MALFORMATION PERFORMED ON (B)(6) 2011, THE POSITIONING ARM OF THE LEYLA RETRACTION SYSTEM SLIPPED CAUSING A LACERATION TO THE MIDDLE CEREBRAL ARTERY. THE TREATMENT WAS A REPAIR OF THE LACERATION TO THE MIDDLE CEREBRAL ARTERY. THE SURGERY TIME WAS PROLONGED BY 10-15 MINUTES FOR THE REPAIR. THE SURGICAL OUTCOME WAS REPORTED AS "GOOD." PER THE DIRECTOR OF BIOMEDICAL ENGINEERING A MEDWATCH REPORT #(B)(4) WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUGGLES LEYLA RETRACTION SYSTEM RIGID HOLDING RETRACTORS GZT INTEGRA YORK, PA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R CLAMP| R2382 RUGGLES LEYLA RETRACTION SYSTEM - COUPLING| R2383 RUGGLES LEYLA RETRACTION SYSTEM - BALL JOINT| HEAD