BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIX PLUS

    MDR report key: 18862975 · Received March 7, 2024

    Report

    Report Number
    3010626093-2024-00002
    Event Type
    Injury
    Date Received
    March 7, 2024
    Report Date
    March 7, 2024
    Manufacturer
    DATUM DENTAL LTD.
    Product Code
    NPL
    UDI-DI
    07290015477727
    PMA / PMN Number
    K160281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    66-YEAR-OLD FEMALE WITH PAST CANCER HX BUT IN REMISSION. NO MEDS CONTRA INDICATING IMPLANT PLACEMENT. HAD A SINGLE ANTHOGYR DELAYED IMPLANT PLACED IN THE LL6 SITE WITH NO THREADS EXPOSED, BUT WITH NEED FOR HORIZONTAL BONE AUGMENTATION. THIS WAS UNDERTAKEN WITH PUROS ALLOGRAFT PARTICLES AND THE 25X 30 MM OSSIX PLUS MEMBRANE STABILIZED WITH PERIOSTEAL SLING SUTURES. THE IMPLANT AND GRAFT WERE BURIED AND THE CLOSURE ACHIEVED BY PRIMARY STABILITY. THE 2-WEEK STITCH REMOVAL WAS UNEVENTFUL AND THE PATIENT HAD NO PAIN AT ANY STAGES. AT THE 3-MONTH EXPOSURE APPOINTMENT, THE SITE HAD A SINUS TRACT WITH PUS DISCHARGE AND THE BONE GRAFT AND IMPLANT WERE COMPLETELY COMPROMISED. THERE WAS SOFT TISSUE INSTEAD OF NEW BONE AND WHEN THIS WAS REMOVED , BUCCAL AND VERTICAL BONE LOSS WAS EVIDENT; DOCTOR EXPLANTED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170946 OSSIX PLUS Barrier, animal source, intraoral NPL DATUM DENTAL LTD. OXP2530 OP2500647 07290015477727

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other ANTHOGYR IMPLANT, PUROS ALLOGRAFT PARTICLES