BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIX K TI CAGE, 9X28MM 5°

    MDR report key: 7399220 · Received April 5, 2018

    Report

    Report Number
    3013248720-2018-00001
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 6, 2018
    Manufacturer
    BIEDERMANN MOTECH GMBH & CO. KG
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI INFORMATION NOT AVAILABLE. PRIMARY DEVICE IDENTIFIER: (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE A REVIEW OF THE DHR AND INSPECTION OF THE DEVICE IS NOT POSSIBLE. THE MANUFACTURER WILL BE INFORMED OF THIS EVENT AND 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

    INFERIOR END PLATE FRACTURE AND A POSTERIOR SHIFT OF THE SUBJECT DEVICE PROMPTED REVISION SURGERY. THERE WERE NO COMPLICATIONS REPORTED DURING THE REMOVAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243468 TELIX K TI CAGE, 9X28MM 5° TELIX K TI CAGE, 9X28MM 5° MAX BIEDERMANN MOTECH GMBH & CO. KG 109-015-0928

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention