BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 2823891 · Received October 29, 2012

    Report

    Report Number
    1045254-2012-00651
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 14, 2011
    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 DEVICE WAS DISCARDED / NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, A REVIEW OF DEVICE HISTORY RECORDS (DHR) FOUND NO NON-CONFORMANCES IN THE PRODUCTION OF THIS LOT. METHOD: REVIEW OF DEVICE HISTORY RECORDS PERFORMED. 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 APPROXIMATELY 0.7 INCHES (18MM) IN LENGTH AND HAS AN APPROXIMATE OUTER DIAMETER OF 0.08 INCHES (2MM). 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 SLIDER; 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. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND NOT RETURNED TO THE MANUFACTURER; THEREFORE NO PRODUCT ANALYSIS IS AVAILABLE. HOWEVER, A REVIEW OF DEVICE HISTORY RECORDS (DHR) FOUND NO NON-CONFORMANCES IN THE PRODUCTION OF THIS LOT. WITHOUT RETURN OF THE DEVICE, IT CANNOT BE DETERMINED WHETHER OR NOT IT FAILED TO MEET SPECIFICATION. NO APPLICABLE IMAGING FILMS OR MEDICAL RECORDS WERE RECEIVED. NO PT INFORMATION/IDENTIFIER WAS SUBMITTED WITH THE ORIGINAL REPORT, WITHOUT WHICH IT IS NOT POSSIBLE TO FOLLOW-UP WITH THE CLINICIAN. THEREFORE, THE AVAILABLE INFORMATION IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. INFORMATION 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 RELATED TO MEDICAL DEVICE REPORT (MDR) DECISIONS REGARDING PILLAR PALATIAL IMPLANTS. THIS CHANGE/IMPROVEMENT, WHICH WAS INITIATED IN JANUARY 2012, HAS RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY THE MANUFACTURER - THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF ANY NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE SUBMISSION CRITERIA. FOUR PROSTHESIS PALATAL ((B)(4)) IMPLANTS WERE IMPLANTED INTO THE SOFT PALATE OF THIS PT. A FEEDBACK FORM RECEIVED FROM THE PHYSICIAN INDICATES THAT THE PT PRESENTED APPROXIMATELY THREE MONTHS POST PROCEDURE WITH ONE IMPLANT PARTIALLY POKING THROUGH THE MUCOSA; IT WAS TRIMMED. ONE MONTH LATER, THE IMPLANT WAS AGAIN EXTRUDING AND TRIMMED, "MAKING IT NON-FUNCTIONAL." AT THAT TIME A SEPARATE IMPLANT HAD EXTRUDED AND WAS COMPLETELY REMOVED. THE PRODUCT WAS DISCARDED - NOT RETURNED FOR EVALUATION. FOLLOW-UP FOUND "THE PT IS DOING FINE." NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT PDS3000M 6PK PILLAR PALATAL LRK - DEVICE, ANTI-SNORING LRK XOMED MFG JACKSONVILLE PDS3000M 73034200

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention