BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE INLINE 5 LOR 9X8X25

    MDR report key: 7870135 · Received September 12, 2018

    Report

    Report Number
    1526439-2018-50878
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 16, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    UDI-DI
    10705034141558
    PMA / PMN Number
    K110694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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 DEVICE #(B)(4) JAMMED BETWEEN THE L5-S1 AND WHEN BEING REMOVED THROUGH ANTERIOR ACCESS THE IMPLANT BROKE INTO TWO PIECES. THIS WAS REPORTED TO SYNTHES VOICEMAIL AND ENTERED AS (B)(4))

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710353 CONCORDE INLINE 5 LOR 9X8X25 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH 187850208 10705034141558

    Patients

    Seq Age Sex Outcome Treatment
    1