BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2920819 · Received January 17, 2013

    Report

    Report Number
    2520274-2013-00422
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 19, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    LITERATURE ARTICLE TITLED: FAILURE OF LOCKED DESIGN-SPECIFIC PLATE FIXATION OF THE PUBIC SYMPHYSIS: A REPORT OF SIX CASES. AUTHORS BERTON R. MOED MD, CHARLES S. GRIMSHAW MD, AND DANIEL N. SEGINA MD. PATIENT INVOLVED IN A MVA IMPLANTED WITH FOUR-HOLE SYMPHYSEAL LOCKING PLATE AND FOUR LOCKING SCREWS RETURNED FOR FOLLOW UP TWELVE WEEKS STATUS POST IMPLANTATION DATE UNSPECIFIED. RADIOGRAPHIC FINDINGS REVEALED LOOSENING OF SYMPHYSEAL HARDWARE, BONE RESORPTION AT THE SCREW-BONE INTERFACE AND GAPPING OF THE PUBIC SYMPHYSEAL REDUCTION. THIS FINDING DID NOT PRODUCE SYMPTOMS OR ELICIT ANY COMPLAINTS FROM THE PATIENT. NO HARM REPORTED PER REVIEWED ARTICLE. THIS REPORT IS #1 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27059 PLATE PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCREWS