BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIX PLUS

    MDR report key: 18862979 · Received March 7, 2024

    Report

    Report Number
    3010626093-2024-00003
    Event Type
    Injury
    Date Received
    March 7, 2024
    Report Date
    March 7, 2024
    Manufacturer
    DATUM DENTAL LTD.
    Product Code
    NPL
    UDI-DI
    07290015477765
    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

    67-YEAR-OLD FEMALE WHO HAS SLEEP APNEA AND OCCASIONALLY TAKES OMEPRAZOLE. REGULAR ATTENDER TO HYGIENIST AND PERIODONTIST. HAD AN IMMEDIATE ANTHOGYR IMPLANT PLACEMENT FOR THE UR1 WITH HORIZONTAL BONE AUGMENTATION USING PUROS ALLOGRAFT AND 15X25 OSSIX PLUS MEMBRANE STABILIZED WITH PERIOSTEAL SLING SUTURES. THE 2-WEEK STITCH REMOVAL WAS UNEVENTFUL, AND THE PATIENT HAD NO REPORTED PAIN OR SWELLING AT ANY STAGES DURING HEALING PHASE. AT THE 3-MONTH EXPOSURE APPOINTMENT, THERE WAS NO OBVIOUS PUS OR SINUS, BUT THE SOFT TISSUE HEALING WAS NOT GOOD AND AT EXPOSURE, SOFT TISSUE INFIL INTO THE GRAFT WAS DISCOVERED. THE IMPLANT WAS COMPROMISED, WITH SOME BONE LOSS AT THE HEAD OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170950 OSSIX PLUS Barrier, animal source, intraoral NPL DATUM DENTAL LTD. OXP1525 OP1500637 07290015477765

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other ANTHOGYR IMPLANT, PUROS ALLOGRAFT PARTICLES.