BEUDAMED
    FDA Adverse Event Other Summary report: N

    WRIST ARTHRODESIS NAIL SYSTEM

    MDR report key: 2310007 · Received October 19, 2011

    Report

    Report Number
    3006742481-2011-00001
    Event Type
    Other
    Date Received
    October 19, 2011
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    SKELETAL DYNAMICS LLC
    Product Code
    HSB
    PMA / PMN Number
    K092720
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DHR SHOWS THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION RELATED TO INCIDENT. PER THE REPRESENTATIVE, THE FOLLOW-UP SURGERY WAS SUCCESSFUL AND NO LONG TERM IMPAIRMENT TO THE PATIENT HAS OCCURRED.

    Description of Event or Problem · 1

    FOLLOW-UP SURGERY PERFORMED IN ORDER TO REPLACE IMPLANT COMPONENT NOT PROPERLY SEATED TO CONNECTED COMPONENT DURING ORIGINAL SURGERY. THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIST ARTHRODESIS NAIL SYSTEM NA HSB SKELETAL DYNAMICS LLC DRW-00218-15RAF AZ071001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention