BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUS INVUE TIPPED DRIVER

    MDR report key: 2588544 · Received May 21, 2012

    Report

    Report Number
    MW5025494
    Event Type
    Injury
    Date Received
    May 21, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 21, 2012
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INDUS CERVICAL SCREW DRIVER WITH NIPPLE TIP BROKE OFF DURING SURGERY. BROKEN DRIVER TIP WAS REMOVED AND ANOTHER ONE INSERTED SUCCESSFULLY. SURGERY COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUS INVUE TIPPED DRIVER INVUE TIPPED DRIVER HAW SPINEFRONTIER, INC. 11-70083 011836-001

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR