BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX FUSION SYSTEM

    MDR report key: 4345435 · Received December 5, 2014

    Report

    Report Number
    3004485144-2014-00017
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 13, 2014
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    MAX
    PMA / PMN Number
    K102738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING FINAL TIGHTENING OF A SCREW INTO HARD BONE AT S1, THE HEX TIPS OF THE SPLIT TIP DRIVER SHEARED OFF AND REMAIN IN THE SCREW HEAD. THE U-JOINT AWL WAS USED TO PREP THE SCREW HOLE; HOWEVER, A GUIDE WAS NOT USED. THE SURGEON CHOSE TO LEAVE THE TIP IN THE PATIENT. THERE WAS ONE MINUTE OF SURGICAL EXTENSION, BUT NO PATIENT HARM OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786308 LANX FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX BIOMET SPINE LLC 8530-1140 L555231A

    Patients

    Seq Age Sex Outcome Treatment
    1