BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING CORTICAL/CANCELLOUS SCREW

    MDR report key: 3335275 · Received September 9, 2013

    Report

    Report Number
    3025141-2013-00094
    Event Type
    Injury
    Date Received
    September 9, 2013
    Date of Event
    July 14, 2011
    Report Date
    September 27, 2012
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR#: PART DESCRIPTION: 3025141-2013-00092 8-HOLE PRECONTOURED CLAVICLE PLATE, 3025141-2013-00093 LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00095 LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00096 LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00097 LOCKING CORTICAL/CANCELLOUS SCREW, 3025141-2013-00098 LOCKING CORTICAL/CANCELLOUS SCREW. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    TWO SCREWS ASSOCIATED WITH AN 8-HOLE PRE-CONTOURED CLAVICLE PLATE LOOSENED REDUCING THE EFFECTIVENESS OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448616 LOCKING CORTICAL/CANCELLOUS SCREW HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention