BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINEROSS

    MDR report key: 21385476 · Received February 14, 2025

    Report

    Report Number
    1287163-2025-00001
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 12, 2025
    Manufacturer
    ACE SURGICAL
    Product Code
    LPK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE CAUSE OF THE INFECTION IS UNKNOWN. WE ARE SUBMITTING THIS REPORT AS A PRECAUTION.

    Description of Event or Problem · 0

    PATIENT HAD A POST OP INFECTION AFTER THE EXTRACTION AND BONE GRAFT. CLINICIAN ALWAYS PUTS HIS PATIENTS ON A COURSE OF ANTIBIOTICS AFTER A SOCKET PRESERVATION. PT TOOK THE COURSE OF ANTIBIOTICS, THEN HAD WORSENING SYMPTOMS. A SECOND COURSE OF ANTIBIOTICS STILL DID NOT CLEAR THE INFECTION, CLINICIAN THEN REMOVED THE BONE GRAFT AND DID A DEBRIDEMENT. CULTURE CAME BACK 'MIXED GRAM-POSITIVE FLORA AND PSEUDOMONAS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151854 MINEROSS CORTICAL & CANNCELLOUS CHIPS LPK ACE SURGICAL BH0082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other