BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW 76353200 REPOSE SYSTEM

    MDR report key: 2870506 · Received December 12, 2012

    Report

    Report Number
    1045254-2012-00709
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT PROVIDED OR AVAILABLE. THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS BEING REPORTED SUBSEQUENT TO THE LITERATURE REVIEW OF THE ARTICLE TITLED "OUTCOMES OF HYOID MYOTOMY AND SUSPENSION USING A MANDIBULAR SCREW SUSPENSION SYSTEM." PUBLISHED BY [HTTP://OTOJOURNAL.ORG] OTOLARYNGOLOGY -- HEAD AND NECK SURGERY 2011 144: 225 ORIGINALLY PUBLISHED ONLINE 23 DECEMBER 2010. AUTHORS: M. BOYD GILLESPIE, CHRISTOPHER M. AYERS, SHAUN A. NGUYEN AND MICHAEL R. ABIDIN. "THREE OF THESE PATIENTS DEVELOPED NECK SEROMAS IN THE WEEK FOLLOWING SURGERY DESPITE THE USE OF PENROSE DRAINS DURING THE FIRST 24 HOURS POSTOPERATIVELY. THE SEROMAS RESPONDED TO SERIAL ASPIRATION AND PRESSURE DRESSINGS. ONE PATIENT DEVELOPED SIGNIFICANT TONGUE EDEMA IN THE IMMEDIATE POSTOPERATIVE PERIOD REQUIRING A 48-HOUR INPATIENT STAY FOR INTRAVENOUS FLUIDS AND STEROIDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW 76353200 REPOSE SYSTEM DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC. 76353200 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention