BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAGUIDE COLLAGEN DENTAL MEMBRANE

    MDR report key: 2563549 · Received May 2, 2012

    Report

    Report Number
    2530154-2012-00007
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    February 18, 2011
    Report Date
    May 2, 2012
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    NPL
    PMA / PMN Number
    K090919
    Removal / Correction Number
    25301540 03132012 01 R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE HISTORY RECORDS WERE REVIEWED. RESULT - THIS LOT WAS SUBJECT TO RECALL (RECALL #(B)(4), INITIATED ON (B)(4) 2012) DUE TO A STERILIZATION PROCESS RELATED ISSUE. THE RECALL WAS NOT INITIATED AS A RESULT OF THE ADVERSE EVENT IN THIS REPORT. THE PRODUCT RECALL WAS INITIATED PRIOR TO DISCOVERY OF THE ADVERSE EVENT IN THIS REPORT. THEREFORE, THIS EVENT IS BEING REPORTED IN A 30 DAY REPORT VERSUS A 5-DAY REPORT. CONCLUSION - IT IS POSSIBLE THAT THE ADVERSE EVENT IN THIS REPORT COULD BE RELATED TO THE REASON FOR PRODUCT RECALL. HOWEVER, A DIRECT RELATIONSHIP CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    A PT PRESENT WITH AN INFECTED #9 TOOTH IMPLANT. THE PT SUBSEQUENTLY HAD SURGERY IN WHICH MINEROSS BONE VOID FILLER WAS PLACED AND COVERED WITH COLLAGUIDE. NON-ABSORBABLE TACKS WERE USED FOR FIXATION AND THE SOFT TISSUE WAS CLOSED WITH CYTOPLAST SUTURE. THE PT TOOK AMOXICILLIN 500MG FOR 7 DAYS POST-OPERATIVE AND PERFORMED MOUTH RINSE WITH BAKING SODA. THE PT HAD AN ASYMPTOMATIC EARLY POST-OPERATIVE COURSE. HOWEVER, APPROX (B)(6) MONTHS LATER, THE PT PRESENTED WITH AN INFECTED #9 IMPLANT, WHICH WAS REMOVED AND FOUNDATION BONE VOID FILLER WAS IMPLANTED. APPROX (B)(6) MONTH LATER, THE #9 IMPLANT LOCATION WAS REPLACED WITH BIO-OSS BONE GRAFT SUBSTITUTE AND COVERED WITH A NEW COLLAGUIDE. AT THE LAST F/U VISIT, THE PT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAGUIDE COLLAGEN DENTAL MEMBRANE NPL KENSEY NASH CORP. 20650-01 88519

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention MINEROSS BONE VOID FILLER| AMOXICILLIN (500MG/DAY FOR 7 DAYS)| CYTOPLAST SUTURE