BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 IM ROD 400MM

    MDR report key: 1943549 · Received November 30, 2010

    Report

    Report Number
    1818910-2010-09285
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 4, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED ROD CONFIRMED THE REPORTED BREAKAGE. THE PRODUCT RETURNED IS OF A PRIOR DESIGN. A CONCLUSIVE ROOT CAUSE WAS NOT IDENTIFIED. ALTHOUGH THE DESIGN HAS BEEN ENHANCED SINCE THE COMPLAINT SAMPLE WAS MFG, THE ROD BREAKAGE MAY ALSO BE RELATED TO A COMBINATION OF INSTRUMENT AGE, SERVICE LIFE, AND/OR USER TECHNIQUE. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN RESPONSE TO A TREND IDENTIFIED PREVIOUSLY FOR THIS PRODUCT CODE, ECO 38103 WAS RELEASED IN JULY OF 2001 CHANGING THE RAW MATERIAL USED AND THE GEOMETRY OF THE ROD. A SEARCH OF THE COMPLAINT DATABASE DID NOT FIND ANY COMPLAINT OF THIS NATURE MFG AFTER THIS CHANGE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE ROD BROKE OFF IN THE PT, PIECE LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SP2 IM ROD 400MM 87 LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR