BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 2901712 · Received January 8, 2013

    Report

    Report Number
    1045254-2013-00016
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK SPACES ON THIS REPORT ARE THE RESULTS OF THE COMPLAINANT OR THE USER FACILITY NOT PROVIDING FURTHER INFORMATION. THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. EXPLANT DATE: (B)(6) 2012. (B)(4). PRODUCT WAS NOT RETURNED TO MANUFACTURING FOR EVALUATION.

    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 ON (B)(6) 2011 FIVE PILLARS WERE INITIALLY INSERTED. THE PATIENT SUFFERED A PARTIAL EXTRUSION WITH TWO OF THE PILLARS AND HAD THESE TWO PILLARS REMOVED IN (B)(6) 2012. THE TWO PILLARS WERE REINSERTED INTO THE PATIENT ON (B)(6) 2012. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9474 IMPLANT PDS3000M 6PK PILLAR PALATAL DEVICE, ANTI-SNORING LRK XOMED MFG JACKSONVILLE PDS3000M 73392700

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention