BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYS

    MDR report key: 3799423 · Received April 25, 2014

    Report

    Report Number
    3004485144-2014-00004
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    MNI
    PMA / PMN Number
    K120399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO BROKEN PEDICLE SCREWS AT S1 LESS THAN 5 MONTHS AFTER INSTALLATION. PER REPORTER, THE PT WAS LIFTING HEAVY ITEMS AT WORK AND IS OBESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251347 LANX SPINAL FIXATION SYS PEDICLE SCREW SPINAL SYSTEM MNI BIOMET SPINE LLC 7712-5535 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention 7701-0400 400MM ROD| 7703-1600 SET SCREWS