BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4289969 · Received November 26, 2014

    Report

    Report Number
    3004485144-2014-00020
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    November 5, 2013
    Report Date
    November 15, 2013
    Manufacturer
    BIOMET SPINE, LLC.
    Product Code
    KWQ
    PMA / PMN Number
    K090316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED TO REMOVE BROKEN DEVICES 10 DAYS AFTER THEY WERE IMPLANTED BECAUSE THE PATIENT WAS INVOLVED IN A TRAUMATIC ACCIDENT. ALTHOUGH IT WAS NOT ABLE TO BE CONFIRMED IT IS BELIEVED THE IMPLANTS BROKE DUE TO THE ACCIDENT AND NOT DUE TO ANY DEVICE MALFUNCTION. THIS MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW CONDUCTED BY BIOMET SPINE. THIS RETROSPECTIVE REVIEW WAS COMPLETED IN RESPONSE TO AN FDA FORM 483 ISSUED TO BIOMET SPINE DURING AN FDA ON-SITE INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769669 LANX ANTERIOR CERVICAL PLATE SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION KWQ BIOMET SPINE, LLC. 4431-2041 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PEEK SPACER: (B)(4)| SCREWS: (B)(4)| LOCKING CAPS: (B)(4)