BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVATION

    MDR report key: 3060995 · Received March 26, 2013

    Report

    Report Number
    1038671-2013-00016
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE IS CURRENTLY UNDERGOING ENGINEERING EVALUATION. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THAT THE DEVICE WAS ACCEPTED WITH CONFORMANCE TO PRODUCT REQUIREMENTS.

    Description of Event or Problem · 1

    DURING IMPACTION OF THE RING OVER THE CUP, ONE OF THE TABS CHIPPED OFF RESULTING IN A DELAY TO SURGERY AS AN ALTERNATE DEVICE WAS RETRIEVED. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123196 NOVATION CONSTRAINING RING LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention