BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPLATE C-TI CERVICAL PLATE/IFD

    MDR report key: 1939646 · Received December 16, 2010

    Report

    Report Number
    3003597504-2010-00002
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 15, 2010
    Manufacturer
    RSB SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K071922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETRIEVED DEVICES DISPOSED. ANALYSIS WAS NOT POSSIBLE. NO DEVIATIONS FOUND IN INSPECTION RECORDS FOR LOTS INVOLVED.

    Description of Event or Problem · 1

    A REPRESENTATIVE NOTIFIED RSB THAT A REOPERATION WAS PLANNED AND PROVIDED AN X-RAY TAKEN IMMEDIATELY PRIOR TO REVISION. INFORMATION ON THE PATIENT AND IMPLANTS USED IN THE PROCEDURE WAS OBTAINED FROM COMPANY RECORDS. THE IMPLANTS WERE NOT AVAILABLE FOR ANALYSIS. THE REPRESENTATIVE CONTACTED THE SURGEON APPROXIMATELY TWO WEEKS AFTER THE REVISION TO SOLICIT ADDITIONAL COMMENTS. THE PATIENT IS OLDER AND HAD OTHER UNSPECIFIED MEDICAL CONDITIONS. THE SURGEON STATED THE FAILURE APPEARED TO BE DUE TO TRAUMA. THE PATIENT WAS LIVING WITH AN ADULT SON AND THE SURGEON SPECULATED THAT IT WAS AN ABUSIVE RELATIONSHIP. THE REVISION OCCURRED TWO YEARS POST-OP. OTHER DIAGNOSES MIGHT TYPICALLY RESULT IN SYMPTOMS EARLIER THAN THAT, SO A TRAUMATIC EVENT MAKES SENSE IN THAT REGARD. THERE IS NO EVIDENCE THE INTERPLATE IMPLANTS CONTRIBUTED TO THE NEED FOR A REVISION SURGERY BUT A REPORT IS BEING FILED BECAUSE REVISION SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPLATE C-TI CERVICAL PLATE/IFD KWQ, ODP KWQ RSB SPINE RSB0612 EJ042

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention