BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUFLEX MCP IMPLANT SZ 30

    MDR report key: 1984448 · Received January 27, 2011

    Report

    Report Number
    1818910-2011-01112
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    K970544
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BASE MATERIAL OF THE IMPLANT, SILICONE, IS SUSCEPTIBLE TO TEARING, AFTER A CUT / TEAR /RIP HAS BEEN INTRODUCED; HOWEVER, THE BASE SILICONE MATERIAL, USED IN THE MANUFACTURE OF THE NEUFLEX FINGER IMPLANT REMAINS AN INDUSTRY LEADER. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO MANUFACTURING DEVIATIONS OR REJECTIONS. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT REVISED FOR FRACTURED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUFLEX MCP IMPLANT SZ 30 87 KYJ KYJ DEPUY ORTHOPAEDICS, INC. NA CX8H51

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention