BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 2406178 · Received January 6, 2012

    Report

    Report Number
    1222315-2012-00001
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    December 3, 2010
    Report Date
    January 6, 2012
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    NPK
    PMA / PMN Number
    K101956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BONE AUGMENTATION WITHOUT IMPLANTATION ON (B)(6) 2010 REGIO 44. BONE CERAMIC 070.203 LOT Y8039 AND MEMBRAGEL 070.101, LOT Y6371 PERIO CUT, AREA STRESS-FREE. ON (B)(6) 2010, PATIENT HAS SWELLING IN AREA. ON (B)(6) 2010, LITTLE PAIN BUT SWELLING, WOUND HEALING WELL WITHOUT DEHISCENCE, SUTURE REMOVAL. ON (B)(6) 2010, FISTULA, DEHISCENCE, LIQUID EXUDING, POINT-SHAPED DEHISCENCE, SOME SWELLING, PUS, PAIN UNDER PRESSURE NACL-SOLUTION RINSED VIA DEHISCENCE, REST OF WOUND IN ICE. ON (B)(6) 1010, BETTER, LESS LIQUID OUT OF DEHISCENCE, RINSING. ON (B)(6) 2010, STILL UNCLEAR RINSING. ON (B)(6) 2010, RINSING, DEHISCENCE STILL OPEN, LIQUID SECRETION DURING RINSING, RINSING WITH NACL. ON (B)(6) 2010, REMOVAL OF COMPLETE CONSTRUCTION, RINSING WITH NACL. ON (B)(6) 2011, PERFORATION OF CORTICALIS, AUGMENTATION USING BIO OSS AND BIO GIDE (GEISTLICH). ON (B)(B) 2011, NICE WOUND HEALING, NO INFLAMMATION, REMOVAL OF SUTURE. ON (B)(6) 2011, NO SWELLING OR REDNESS. ON (B)(6) 2011, MOUTH HYGIENE NOT OPTIMAL, A LOT OF PLAQUE. ON (B)(6) 2011, IMPLANTATION REGIO 44 WITH IMPLANT 033.52S LOT AP054. ON (B)(6) 2011, WELL AND NICE WOUND HEALING, OSSTELL MEASUREMENT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL NPK - BARRIER MEMBRANE NPK INSTITUT STRAUMANN AG Y6371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPIRE DATE: 06/30/2015, PROD. CODE LYC -| BONE CERAMIC: CATALOG #070.203, LOT Y8039| SYNTHETIC BONE GRAFTING MATERIAL