BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPI-GUIDE BIORESORBABLE BARRIER MATRIX

    MDR report key: 3121773 · Received May 13, 2013

    Report

    Report Number
    2530154-2013-00003
    Event Type
    Injury
    Date Received
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    LYC
    PMA / PMN Number
    K940643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD CODE: THE DEVICE LOT NUMBER WAS REQUESTED FROM THE AUTHOR FOR LOT HISTORY RECORD EVALUATION. ADDITIONAL DEVICE USE INFORMATION WAS REQUESTED FROM THE AUTHOR.

    Description of Event or Problem · 1

    THE MANUFACTURER IDENTIFIED AN ARTICLE THAT REPORTS A SERIOUS COMPLICATION PRESUMED TO BE RELATED TO EPI-GUIDE BIORESORBABLE BARRIER MATRIX. MAU LP, CHENG CW, HSIEH PY AND JONES AA. BIOLOGICAL COMPLICATION IN GUIDED BONE REGENERATION WITH A POLYLACTIC ACID MEMBRANE: A CASE REPORT IMPLANT DENT 2012;21:171-174. MATERIALS AND METHODS: A HEALTHY 42-YEAR-OLD PATIENT COMPLAINED OF PERSISTENT DISCOMFORT OF THE MAXILLARY ANTERIOR GINGIVA. CLINICAL EXAMINATION AND RADIOGRAPHS SHOWED SEVERE PERIODONTAL DESTRUCTION OF TEETH 7 THROUGH 10. TEETH EXTRACTION WAS FOLLOWED BY EARLY IMPLANT PLACEMENT WITH GBR. RESULTS: FOUR MONTHS LATER, SEVERE BONE RESORPTION WAS OBSERVED UPON SURGICAL EXPOSURE. A SECOND GBR WAS PERFORMED. WOUND HEALING PROGRESSED UNEVENTFULLY AND AN IMPLANT-SUPPORTED FIXED PARTIAL DENTURE WAS LATER LOADED. CONCLUSION: WE PRESUME THAT THIS COMPLICATION WAS A FOREIGN BODY REACTION TO THE POLYLACTIC ACID MEMBRANE. SUCH A REACTION CAN AFFECT SOFT AND HARD TISSUE HEALING FOLLOWING GBR. LONG-TERM FOLLOW-UP IS NEEDED TO DETERMINE STABILITY OF THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211037 EPI-GUIDE BIORESORBABLE BARRIER MATRIX LYC KENSEY NASH CORP. 50600-03

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SLA NN SP IMPLANTS (STRAUMANN)| ORAGRAFT (LIFENET HEALTH)