BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRVANCE BONE SCREW (REPOSE) SYSTEM

    MDR report key: 3654126 · Received March 3, 2014

    Report

    Report Number
    1045254-2014-00049
    Event Type
    Injury
    Date Received
    March 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (1) REPOSE BONE SCREW SYSTEM (76353200M); LOT: 0207247530; MANUFACTURED: JULY 26, 2013; EXPIRATION: JULY 26, 2015; 510K: K981677 (2) REPOSE BONE SCREW (76310200M); LOT: 0207287764; MANUFACTURED: AUGUST 09, 2013; EXPIRATION: AUGUST 09, 2015; 510K: K981677. (B)(4): PART OF THIS DEVICE REMAINS IN THE PATIENT AND THE OTHER PORTION WAS DISPOSED OF. NO DEVICES WILL BE RETURNING. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. METHOD: NO TESTING METHODS PERFORMED. (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    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 THAT A FEMALE PATIENT OF APPROXIMATELY 46 YEARS IN AGE COMPLAINED OF POST-OPERATIVE PAIN AND INFECTION ¿WITH THE TONGUE PART¿ OF A HYOID AND/OR TONGUE SUSPENSION SURGERY PERFORMED ON (B)(6) 2012, USING THE REPOSE SYSTEM (MEDTRONIC AIRVANCE BONE SCREW SYSTEM). ANY IMPACT FROM THE PAIN AND/OR INFECTION WAS DESCRIBED AS BEING ONLY ¿TEMPORARY¿ IN NATURE, WITH NO SIGNIFICANT INTERVENTION OR TREATMENT REQUIRED¿AS IT WAS ALSO REPORTED THAT AN ADDITIONAL PROCEDURE WAS PERFORMED ONLY FOR ¿SUTURE REMOVAL¿. FURTHERMORE, UPON REQUEST OF AN UPDATE ON THE PATIENT¿S CURRENT STATUS¿A REPORT OF ¿SHE IS HOME DOING WELL¿ WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127377 AIRVANCE BONE SCREW (REPOSE) SYSTEM DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED INC. 76353200M 0207229013

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention