BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SCREW

    MDR report key: 1945667 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09422
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    October 14, 2009
    Report Date
    November 30, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    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

    PT'S ATTORNEY ALLEGES THE PT UNDERWENT INVASIVE SURGERY ON (B)(6) 2009 FOLLOWING AN INFECTION AND OTHER COMPLICATIONS RESULTING FROM A BROKEN DVR PLATE. THE PT'S MEDICAL RECORDS INDICATE THE PT WAS REVISED TO ADDRESS FRACTURE OF THE PLATE AND NON-UNION. UPDATE: (B)(6) 2010 - LITIGATION PAPERS WERE RECEIVED. INDICATING REVISION OF A FRACTURED PLATE AND SCREW DUE TO NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SCREW TRAUMA FIXATION HSB DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention