BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALEO SPACER SYSTEM

    MDR report key: 2511509 · Received March 30, 2012

    Report

    Report Number
    3005032068-2012-00003
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 28, 2012
    Manufacturer
    AMEDICA CORP.
    Product Code
    MAX
    PMA / PMN Number
    K091278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MORE DATA MAY BECOME AVAILABLE AFTER DEVICE IS RETURNED TO AND EVALUATED BY MFR. RETURN HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    SINGLE VALEO PL SPINAL DEVICE WAS IMPLANTED ON (B)(6). PT WAS REPORTEDLY NON-COMPLIANT AND REMOVED HER BACK BRACE. SHE HAD PAIN/NUMBNESS AND LOSS OF BLADDER CONTROL. WHEN SURGEON REVIEWED FLUOROSCOPY, THE IMPLANT HAD MIGRATED. SURGEON SURGICALLY REMOVED DEVICE ON (B)(6). AS OF (B)(6), PT WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO SPACER SYSTEM ORTHOSIS, SPINAL INTERVENTION FUSION MAX AMEDICA CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention