BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 2801139 · Received October 17, 2012

    Report

    Report Number
    1045254-2012-00467
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    November 17, 2009
    Report Date
    November 23, 2009
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED/NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 PATIENTS 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. THE IMPLANT IS A BRAIDED SEGMENT OF POLYESTER FILAMENTS INTENDED FOR PERMANENT IMPLANTATION. 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 NOT 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. 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 PATIENT INFORMATION/IDENTIFIER WAS SUBMITTED WITH THE ORIGINAL REPORT, WITHOUT WHICH IT IS NOT POSSIBLE TO FOLLOW-UP WITH THE CLINICIAN FOR ANY MISSING INFORMATION. THEREFORE, THE AVAILABLE INFORMATION IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. WITHOUT INFORMATION TO REASONABLY SUGGEST A SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A 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 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. IT WAS REPORTED BY THE PHYSICIAN THAT 3 PROSTHESIS PALATAL (BRAIDED POLYESTER FILAMENT) IMPLANTS WERE IMPLANTED INTO THE SOFT PALATE; ONE IMPLANT EXTRUDED WITHIN 24 HOURS OF PROCEDURE AND A FOREIGN BODY SENSATION IS REPORTED. THE SAMPLE WAS NOT RETURNED AND A REPLACEMENT WAS SENT TO THE CUSTOMER. FOLLOW-UP INDICATES THAT THE "REPLACEMENT SURGERY WENT WELL; PT. IS DOING FINE." NO OTHER INFORMATION WAS PROVIDED.

    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 60804900

    Patients

    Seq Age Sex Outcome Treatment
    1