BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKHAWK CERVICAL SPACER SYSTEM

    MDR report key: 9607076 · Received January 20, 2020

    Report

    Report Number
    3005819474-2018-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2020
    Date of Event
    March 26, 2018
    Report Date
    August 14, 2018
    Manufacturer
    CHOICESPINE, LP
    Product Code
    OVE
    UDI-DI
    00840996164535
    PMA / PMN Number
    K132582
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED THAT FOLLOWUP XRAYS SHOWED THE ANCHORS WERE NOT LOCKED AND THE IMPLANT HAS BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72142 BLACKHAWK CERVICAL SPACER SYSTEM INTERVERTEBRAL BODY FUSION DEVICE OVE CHOICESPINE, LP 05-090-22-1405 00840996164535

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR