BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SULZER SPINE-TECH BONE HARVESTER

    MDR report key: 329435 · Received April 24, 2001

    Report

    Report Number
    2184052-2001-00002
    Event Type
    Malfunction
    Date Received
    April 24, 2001
    Date of Event
    March 23, 2001
    Report Date
    April 17, 2001
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DISTAL TIP OF THE BONE HARVESTER BROKE OFF IN THE PATIENT'S ILIAC CREST. ALL PIECES OF THE DEVICE WERE RETRIEVED. THIS INCIDENT LED TO A DELAY IN SURGERY OF APPROXIMATELY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18943 SULZER SPINE-TECH BONE HARVESTER BONE HARVESTER HWE SULZER SPINE-TECH NA P990501

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention