BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARB-EDGE MAYO SCS 6-3/4 STR

    MDR report key: 7645957 · Received June 28, 2018

    Report

    Report Number
    2523190-2018-00081
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 5, 2018
    Report Date
    June 11, 2018
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    LRW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. THE LOT NUMBER/SERIAL NUMBER WAS NOT RECEIVED TO PERFORM DHR REVIEW. A FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    SUS VOLUNTARY EVENT REPORT FOI FOR MANUFACTURERS (MW5077809) WAS RECEIVED ON 21JUN2018 WITH THE FOLLOWING INFORMATION: ON (B)(6) 2018, DURING THE TIBIAL AND FIBULA OPEN REDUCTION INTERNAL FIXATION PROCEDURE, THE TIP OF 101220 CARB-EDGE MAYO SCS BROKE OFF IN THE SURGICAL SITE AND THE TIP WAS UNABLE TO BE REM OVED. NO OTHER CLINICAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487992 CARB-EDGE MAYO SCS 6-3/4 STR N/A LRW INTEGRA YORK, PA INC. 100084-1701

    Patients

    Seq Age Sex Outcome Treatment
    1