BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW 76353200 REPOSE SYSTEM

    MDR report key: 2220808 · Received August 23, 2011

    Report

    Report Number
    1045254-2011-00063
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT HE "TOOK A PATIENT BACK TO SURGERY WHO HAD DEVELOPED SEVERE DYSPHAGIA AFTER A TONGUE/HYOID PROCEDURE HAD BEEN DONE APPROXIMATELY 1 YEAR AGO". DURING THE PROCEDURE, IT WAS NOTED THE PATIENT HAD DEVELOPED HETEROTROPHIC BONE FORMATION FROM THE HYOID EXTENDING AND ENCASING THE SUTURES TO THE MANDIBLE. THE HYOID SUTURES AND HETEROTROPHIC BONE WERE REMOVED AND SENT TO PATHOLOGY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "GOOD". THE HYOID SUSPENSION SYSTEM ADVANCES THE BASE OF THE TONGUE AND THE HYOID BONE TO PREVENT OBSTRUCTIONS OF THE AIRWAY DURING SLEEP. IT IS A MINIMALLY INVASIVE, LOW MORBIDITY OPTION TO TREAT PATIENTS SUFFERING FROM OBSTRUCTIVE SLEEP APNEA. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE RE PORTED EVENT. COMPLAINT HISTORY RECORDS FOR SIMILAR LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW 76353200 REPOSE SYSTEM BONE GRAFTING MATERIAL, FOR DENTAL BONE REPAIR LRK MEDTRONIC XOMED, INC 76353200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention