BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR

    MDR report key: 3964670 · Received July 29, 2014

    Report

    Report Number
    2520274-2014-12874
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MAX
    PMA / PMN Number
    PK072253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT INFERIOR SYNFIX LR SCREW HAD LOOSENED POSTOPERATIVE AND THEREFORE NEEDED TO BE REMOVED. THIS IS REPORT 1 OF 3 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441881 4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR SPINAL VERTEBRAL BODY REPLACEMENT DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention