BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE SYSTEM

    MDR report key: 7515777 · Received May 15, 2018

    Report

    Report Number
    3008792120-2018-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    May 11, 2018
    Report Date
    May 15, 2018
    Manufacturer
    SIESTA MEDICAL INC.
    Product Code
    ORY
    PMA / PMN Number
    K133680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO SIESTA MEDICAL, THEREFORE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE EVENT. ALTHOUGH THE CAUSE OF THE FAILURE OF THE DEVICE IS UNKNOWN, THIS MDR IS BEING FILED FOR NOTIFICATION PURPOSES. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL FORM WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, 4 WEEKS POST HYOID SUSPENSION SURGERY, PATIENT REPORTED TO PHYSICIAN THAT HE HEARD A "POP". THE PHYSICIAN BELIEVED THAT THIS WAS DUE TO SUTURE BREAKAGE BUT NO INVESTIGATION WAS REPORTED AT THE TIME TO CONFIRM. ON (B)(6) 2018 THE PHYSICIAN REPORTED THA THE PATIENT HAD SOME RECURRENCE OF HIS SLEEP APNEA. ON (B)(6) 2018, THE PHYSICIAN PERFORMED EXPLORATORY SURGERY TO DETERMINE IF THE SUSPENSION SUTURE HAD INDEED BROKEN. DURING THE SURGERY AND UPON DISSECTION DOWN TO THE HYOID BONE, HE OBSERVED THAT BOTH SUSPENSION LINES (SUTURES) HAD BROKEN. IT WAS NO CLEAR WHAT CAUSED THE SUTURES TO BREAK. THE PHYSICIAN THEN REVISED THE HYOID SUSPENSION BY REPLACING BOTH BONE SCREWS, INSURING THAT THE EYELETS WERE PROPERLY ORIENTED AND SUSPENDING THE HYOID BONE USING ARTHREX FIBERWIRE #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358815 ENCORE SYSTEM TONGUE/HYOID SUSPENSION ORY SIESTA MEDICAL INC. FG0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention