BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW 76353200 REPOSE SYSTEM

    MDR report key: 2546149 · Received April 18, 2012

    Report

    Report Number
    1045254-2012-00179
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 15, 2002
    Manufacturer
    INFLUENT MEDICAL, LLC
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION: ONLY THE MONTH AND YR ARE VALID, THE DAY IS UNK. THIS INFO WAS VALID AT THE TIME OF THE EVENT IN 2002. UNK IF ADDRESS AND PHONE NUMBER ARE STILL VALID. NOTE: THE ASSETS OF (B)(6) REGARDING THE REPOSE DEVICE WERE PURCHASED BY MEDTRONIC XOMED, INC. IN 2008. IN A SUBSEQUENT REVIEW OF (B)(6) COMPLAINT RECORDS OBTAINED DURING THE ACQUISITION, THIS EVENT WAS IDENTIFIED, AND (TO THE BEST OF OUR KNOWLEDGE) WAS FOUND NOT TO HAVE BEEN REPORTED TO THE FDA IN A MDR BY THE MFR. WHILE MEDTRONIC XOMED DID NOT RETAIN THE LIABILITIES AND RESPONSIBILITIES OF (B)(6) FOR THE REPOSE DEVICES MANUFACTURED BY THEM PRIOR TO THE ACQUISITION, WE FELT IT WAS APPROPRIATE TO SUBMIT THIS MEDICAL DEVICE REPORT.

    Description of Event or Problem · 1

    AN ORAL SURGEON REPORTED TO INFLUENT MEDICAL THAT HE REMOVED A REPOSE BONE SCREW FROM A PT THAT HAD DEVELOPED AN INFECTION AROUND THE SCREW. THE DATE OF THE ORIGINAL IMPLANTATION IS UNK BUT WAS APPROX 2 YRS PRIOR TO THE DEVELOPMENT OF THE INFECTION. IT IS UNK AS TO WHETHER ANTIBIOTICS OR OTHER INTERVENTION TOOK PLACE, BESIDES THE SCREW REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW 76353200 REPOSE SYSTEM LRK - DEVICE, ANTI-SNORING LRK INFLUENT MEDICAL, LLC 76353200 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention