BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROI-C MONOBLOCK TRIAL 14X17MM H7MM (YELLOW)

    MDR report key: 3080662 · Received April 9, 2013

    Report

    Report Number
    3004903783-2013-00002
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    April 11, 2012
    Report Date
    April 9, 2013
    Manufacturer
    LDR MEDICAL
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REPORT RECEIVED STATING THAT A PT MAY HAVE BEEN INJURED DURING AN ANTERIOR CERVICAL DISCECTOMY. INVESTIGATION ON-GOING. PLEASE REF MFR #3004788213-2013-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148071 ROI-C MONOBLOCK TRIAL 14X17MM H7MM (YELLOW) CERVICAL IMPLANT TRIAL INSTRUMENT ODP LDR MEDICAL MC9041R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability