BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAGLIDE+

    MDR report key: 4071914 · Received August 11, 2014

    Report

    Report Number
    9614209-2014-00068
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. DEVICE DETAILS, AND EVENT DETAILS HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MFG RECORDS TO BE REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USE. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DISTRIBUTER, MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE RTK IMPACTOR HAS BROKEN. THIS REPORT IS FILED AS IT IS UNK TO THE MFR IF THE EVENT HAPPENED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476253 ROTAGLIDE+ MODULAR KNEE SYSTEM W/FIXED MENISCUS JWH CORIN MEDICAL, LTD. 255.040 187630-03

    Patients

    Seq Age Sex Outcome Treatment
    1