BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT PDS3000ME PILLAR PALATAL

    MDR report key: 2489947 · Received March 13, 2012

    Report

    Report Number
    1045254-2012-00065
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE PILLAR SYSTEM 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 OSA (OBSTRUCTIVE SLEEP APNEA). INDICATIONS FOR USE OF THE SYSTEM INCLUDE: SYMPTOMATIC, HABITUAL, SOCIAL SNORING DUE TO PALATAL FLUTTER OR UPPER AIRWAY OBSTRUCTION CAUSED BY THE SOFT PALATE. THE SYSTEM CONSISTS OF A DELIVERY TOOL AND AN IMPLANT. THE DELIVERY TOOL COMES PRELOADED WITH THE IMPLANT. THE IMPLANT IS A (B)(4) INTENDED FOR PERMANENT IMPLANTATION. THE IMPLANT IS APPROXIMATELY 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 SLIDER; AND THE DELIVERY TOOL IS REMOVED. THE DELIVERY TOOL IS DISPOSABLE. A PARTIAL EXTRUSION OCCURS WHEN THE IMPLANT IS PLACED TOO SHALLOW OR TOO DEEP, AND THE TIP OF THE IMPLANT PROTRUDES THROUGH THE SURFACE OF THE SOFT PALATE TISSUE. IF A PARTIAL EXTRUSION OCCURS, THE PHYSICIAN SHOULD REMOVE THE IMPLANT AND REPLACE IT WITH A NEW IMPLANT. THE INSTRUCTIONS FOR USE (IFU) WARNINGS INCLUDE: AVOID INSERTING INTO THE UVULA OR TOO FAR LATERALLY AS THE PALATE IS USUALLY THINNER IN THIS AREA AND SUBSEQUENT PARTIAL/FULL EXTRUSION OF THE IMPLANTS MAY OCCUR. ATTEMPTING TO PLACE THE IMPLANT INTO A PATHWAY THAT HAS A BREACH ON THE NASOPHARYNGEAL ASPECT OF THE PALATE MAY RESULT IN EXTRUSION OF THE IMPLANT. IF THE IMPLANT IS VISIBLE, IT HAS BEEN PLACED TOO SUPERFICIALLY AND MUST BE REMOVED AND REPLACED WITH A NEW IMPLANT. IMPLANTS PLACED TOO SUPERFICIALLY MAY RESULT IN PARTIAL OR FULL EXTRUSIONS. DO NOT REPOSITION THE NEEDLE IN THE ORIGINAL PENETRATION SITE.

    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 THREE PALATAL (B)(4) IMPLANTS WERE IMPLANTED INTO THE SOFT PALATE. ONE IMPLANT WAS REMOVED AFTER IT EXTRUDED. THERE WAS NO REPORT OF PATIENT INJURY OR PERMANENT IMPAIRMENT. THE EXTRUDED DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT PDS3000ME PILLAR PALATAL DEVICE, ANTI-SNORING LRK XOMED MFG JACKSONVILLE PDS3000ME 0205530524

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR