BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KERRISON RONGEUR (40 DEG FWD), 4MM

    MDR report key: 1556441 · Received December 8, 2009

    Report

    Report Number
    1649384-2009-00396
    Event Type
    Injury
    Date Received
    December 8, 2009
    Date of Event
    November 6, 2009
    Report Date
    December 8, 2009
    Manufacturer
    ZIMMER SPINE
    Product Code
    HTX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MANUFACTURE DATE IS UNKNOWN. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2009, THE DISTRIBUTOR REPORTED THAT DURING SURGERY, THERE WAS A SMALL HOLDING SCREW BROKE. THE FRAGMENT WAS RETRIEVED. THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON RONGEUR (40 DEG FWD), 4MM HARMONY HTX ZIMMER SPINE 18ZG

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention