BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACAPELLA ONE 14X16X6 LOR CERVICAL SPACER

    MDR report key: 6177111 · Received December 15, 2016

    Report

    Report Number
    1038681-2016-00859
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    EXACTECH, INC
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    REPORTED INCIDENT OF THE ACAPELLA ONE DEVICE PARTIALLY OR FULLY BACKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826392 ACAPELLA ONE 14X16X6 LOR CERVICAL SPACER ACAPELLA ONE OVE EXACTECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention