BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMEND

    MDR report key: 5268267 · Received December 4, 2015

    Report

    Report Number
    2249852-2015-00002
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    March 31, 2015
    Report Date
    December 4, 2015
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    PMA / PMN Number
    K011695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS INITIALLY SUBMITTED TO THE FDA VIA US POSTAL SERVICE ON 04/23/2015. BASED ON THE COMMUNICATIONS BETWEEN COLLAGEN MATRIX, INC. AND THE FDA IT APPEARS THAT THIS REPORT WAS LOST AND NOT RECEIVED BY THE FDA. AS PER FDA REQUEST THIS REPORT IS BEING RE-SUBMITTED THROUGH THE EMDR SYSTEM. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT DEVELOPED DRY SOCKET AFTER SURGERY, RESULTING IN PAIN, INFECTION, WOUND DEHISCENCE AND BONE LOSS [BONE GRAFT MATERIAL LOSS].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797560 ZIMMER BIOMEND COLLAGEN DENTAL MEMBRANE NPL COLLAGEN MATRIX, INC. CDMN13M3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other