BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIAL PERFORATOR, 14-11 MM

    MDR report key: 3082468 · Received April 25, 2013

    Report

    Report Number
    1045834-2013-02057
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    June 28, 2011
    Report Date
    July 13, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K082637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DATABASE REVEALED NO OTHER EVENTS FOR THE REPORTED PRODUCTION BATCH. A REVIEW OF TRENDING REPORTS DID NOT INDICATE AN INCREASE IN COMPLAINTS OF THIS NATURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND WAS IN THE POSSESSION OF THE RISK MANAGER FOR THE USER FACILITY; THEREFORE, NO FURTHER INVESTIGATION COULD BE CONDUCTED FOR THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND IS RELATED TO THE FOLLOWING PREVIOUSLY SUBMITTED REPORTS: 1045834-2001-4, 1045834-2011-4-01.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA. THE DEVICE WAS BEING USED WITH AN UNSPECIFIED DRILL AND SPEED REDUCER DURING A SURGICAL PROCEDURE. INFORMATION FROM THE USER FACILITY INDICATED THE DEVICE STOPPED TWICE DURING THE PROCEDURE. WHEN THE DEVICE STOPPED FOR THE SECOND TIME, THE PATIENT SUSTAINED A TEAR TO THE DURA. THE PATIENT WAS TREATED WITH AN UNSPECIFIED DURA REPLACEMENT PRODUCT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180180 CRANIAL PERFORATOR, 14-11 MM HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention