BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC CRILE-WOOD NH 7 MATTE

    MDR report key: 7448349 · Received April 20, 2018

    Report

    Report Number
    2523190-2018-00058
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 29, 2018
    Report Date
    April 2, 2018
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED. THE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 2. A CUSTOMER REPORTED TO INTEGRA THAT A 123131 TC CRILE-WOOD NH 7 MATTE WAS USED ON (B)(6) 2018 DURING AN UNSPECIFIED PROCEDURE. IT WAS STATED THAT THE TIP OF SERRATION BROKE OFF INTRA-OPERATIVELY WHEN THE SURGEON USED A 3-0 NEEDLE WITH THE NEEDLE-HOLDER. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 INDICATING THAT THE BROKEN PIECE WAS NOT RETRIEVED. THE DEVICE WAS IN CONTACT WITH THE PATIENT BUT NO PATIENT INJURY OR SURGERY DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291919 TC CRILE-WOOD NH 7 MATTE N/A MDM INTEGRA YORK, PA INC. 101900

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR