BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL CLAVICLE PLT 2.3MM 16 HOLE, LEFT

    MDR report key: 3973102 · Received August 1, 2014

    Report

    Report Number
    3025141-2014-00178
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 4, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K112111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00177 ACU-SINCH FOLLOW UP 1.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00177 ACU-SINCH SYSTEM.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CLAVICLE PLATE ALONG WITH AN ACU-SINCH SOFT TISSUE REPAIR SYSTEM. ONE DAY AFTER SURGERY, THE ACU-SINCH ANCHOR PULLED OUT OF THE CORACOID BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449742 DISTAL CLAVICLE PLT 2.3MM 16 HOLE, LEFT PLATE, FIXATION, BONE HRS ACUMED LLC 70-0124 229785

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR