BEUDAMED
    FDA Adverse Event Other Summary report: N

    VALEO OL

    MDR report key: 4589512 · Received March 9, 2015

    Report

    Report Number
    3005032068-2015-00001
    Event Type
    Other
    Date Received
    March 9, 2015
    Date of Event
    February 10, 2015
    Report Date
    March 9, 2015
    Manufacturer
    AMEDICA CORP.
    Product Code
    MAX
    PMA / PMN Number
    K091278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EXPLANTED ON (B)(6) AND SENT OUT FOR PATHOLOGY EVAL. RESULTS OF THE EVAL SHOWED HEAVY PROPIONIBACTERIUM ACNES. THE DEVICE HAS NOT YET BEEN RETURNED TO AMEDICA FOR MECHANICAL EVAL.

    Description of Event or Problem · 1

    THE SURGEON REPORTED A DISC SPACE INFECTION. SCHEDULE REVISION FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160417 VALEO OL INTERBODY FUSION DEVICE MAX AMEDICA CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention