BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALSTEAD FCPS 5 CVD MIRROR

    MDR report key: 2433652 · Received January 10, 2012

    Report

    Report Number
    2523190-2012-00007
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 10, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    PER CUSTOMER - TIP BROKE OFF DURING SURGERY. ON (B)(6) 2012 PER THE MATERIALS COORDINATOR, DURING A LUMBAR SPINE STIMULATOR SURGERY, ONE SIDE OF THE CLAMP WAS DISCOVERED TO BE MISSING WHEN THE SURGEON HANDED BACK THE DEVICE TO ASSISTANT DURING THE SURGERY. THE SURGERY WAS DELAYED FOR "A FEW MINUTES" FOR AN X-RAY TO BE TAKEN, THE MISSING TIP WAS NOT VISUALIZED ON X-RAY. NO FURTHER TREATMENT WAS PROVIDED. A VISUAL CHECK OF THE SURGICAL FIELD AND SURROUNDING AREA WAS PERFORMED; THE TIP OF THE DEVICE WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALSTEAD FCPS 5 CVD MIRROR NA EJG INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1