BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW STEP DRILL GAMMA3 Ø10.5X495 MM

    MDR report key: 2974025 · Received February 22, 2013

    Report

    Report Number
    0009610622-2013-00061
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE CONNECTION BETWEEN ITEM 702628 AND 1320-0190 IS SLOW AND HARD AND WOULD NOT FIT CORRECTLY. THEY HAVE BOUGHT A NEW ITEM 702628, BUT THE PROBLEM STILL EXISTS. DURING SURGERY 27/1 THE SURGEON HAD PROBLEM TO PERFORM THE PROCEDURAL STEP CORRECTLY BECAUSE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78719 LAG SCREW STEP DRILL GAMMA3 Ø10.5X495 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1