BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT POS3000M 6PK PILLAR PALATAL

    MDR report key: 2804258 · Received October 22, 2012

    Report

    Report Number
    1045254-2012-00523
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS DISCARDED - NOT RETURNED TO THE MFR FOR EVAL. THE REMAINING UNUSED LOT WAS RETURNED. PRODUCT ANALYSIS OF A SAMPLE FROM THE LOT FOUND NO DEVICE FAULT. NOR WERE ANY MFG NON-CONFORMANCES FOUND IN THE DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS LOT. EVAL CODES: METHOD - A DEVICE FROM THE SAME LOT OF THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED; LABELING EVAL; OTHER - REVIEW OF DEVICE HISTORY RECORDS PERFORMED. RESULTS: NO FAILURE DETECTED. CONCLUSIONS: NO DEVICE FAILURE. THE IMPLANT IS INTENDED FOR USE IN STIFFENING THE SOFT PALATE TISSUE, WHICH MAY REDUCE THE SEVERITY OF SNORING IN SOME INDIVIDUALS, AND FOR THE REDUCTION OF THE INCIDENCE OF AIRWAY OBSTRUCTIONS IN PTS SUFFERING FROM MILD TO MODERATE OBSTRUCTIVE SLEEP APNEA (OSA). THE SYSTEM CONSISTS OF A DELIVERY TOOL AND AN IMPLANT. THE DELIVERY TOOL COMES PRELOADED WITH THE IMPLANT. (B)(4). THE IMPLANT IS APPROX 0.7 INCHES (18MM) IN LENGTH AND HAS AN APPROXIMATE OUTER DIAMETER OF 0.08 INCHES (2 MM). THE DELIVERY TOOL CONSISTS OF A HANDLE AND 14-GAUGE NEEDLE. THE NEEDLE IS INSERTED INTO THE SOFT PALATE; THE IMPLANT IS DEPLOYED BY ADVANCING THE SLIDE; AND THE DELIVERY TOOL IS REMOVED. THE DELIVERY TOOL IS DISPOSABLE. USE OF THE IMPLANT INVOLVES POTENTIAL RISKS NORMALLY ASSOCIATED WITH THE USE OF ANY IMPLANTED DEVICE, INCLUDING, BUT NOT LIMITED TO, IMPLANT MIGRATION AND PARTIAL / FULL EXTRUSION OF THE IMPLANT. THE RELATIONSHIP OF THE DEVICE TO THE REPORTED INCIDENT IS UNCLEAR. PRODUCT ANALYSIS FOUND NO DEVICE FAULT. NO PT INFO/IDENTIFIER WAS SUBMITTED WITH THE ORIGINAL REPORT, WITHOUT WHICH IT IS NOT POSSIBLE TO F/U WITH THE CLINICIAN FOR ANY MISSING DATA. THEREFORE, THE AVAILABLE INFO IS INCONCLUSIVE AS TO THE CAUSE OF THIS EVENT. INFO RECEIVED REASONABLY SUGGESTS SERIOUS INJURY, OR MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY, THUS WE ARE FILING THIS REPORT AS AN ADVERSE EVENT AND PRODUCT PROBLEM.

    Description of Event or Problem · 1

    THIS REPORT IS PROVIDED AS A PART OF A RETROSPECTIVE REVIEW, AND WAS PERFORMED AS THE RESULT OF RECENT CHANGES/IMPROVEMENTS TO PRODUCT SPECIFIC CRITERIA DEVELOPED TO MAKE MEDICAL DEVICE REPORT (MDR) DECISIONS RELATED TO THE PILLAR PALATIAL IMPLANTS, PER DISCUSSION WITH OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB). THIS CHANGE/IMPROVEMENT, WHICH WAS INITIATED IN JANUARY 2012, HAS RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY THE MFR - THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF ANY NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION OF THE SUBMISSION CRITERIA. IT WAS REPORTED BY THE PHYSICIAN THAT FIVE PROSTHESIS PALATAL ((B)(4)) IMPLANTS WERE IMPLANTED INTO THE SOFT PALATE. APPROX THREE WEEKS POST-SURGERY, ONE IMPLANT WAS FOUND TO BE PARTIALLY EXTRUDED THROUGH THE MUCOSA (IMPLANT MIGRATION). PAIN OR DIFFICULTY SWALLOWING, AND FOREIGN BODY SENSATION WERE NOTED. THE SPECIFIC DEVICE WAS DISCARDED, HOWEVER THE UNUSED PORTION OF THE LOT WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT POS3000M 6PK PILLAR PALATAL LRK - DEVICE, ANTI-SNORING LRK XOMED MFG JACKSONVILLE PDS3000M 69053500

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention