BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIBSON HEALTHCARE BONE GRAFT PLUG

    MDR report key: 19703744 · Received July 9, 2024

    Report

    Report Number
    2249852-2024-00013
    Event Type
    Injury
    Date Received
    July 9, 2024
    Report Date
    July 9, 2024
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    LYC
    PMA / PMN Number
    K083742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUBSEQUENT PRODUCT CODE FOR SUSPECT MEDICAL DEVICE IS NPM. PRODUCT CODE: NPM. PRODUCT CODE NAME: BONE GRAFTING MATERIAL, ANIMAL SOURCE. DEVICE CLASS: CLASS II. CLASSIFICATION PANEL: 76-DENTAL. C.F.R SECTION: 872.3930 - BONE GRAFTING MATERIAL.

    Description of Event or Problem · 0

    PATIENT CAME IN FOR A HEMISECTION ON (B)(6) 2024. GIBSON BONE GRAFT WAS USED FOR THE INITIAL PROCEDURE. CUSTOMER STATED THE FLAP WAS LAID AND THE BONE GRAFT PRODUCT WAS CONDENSED INTO THE ROOT SPACE. THERE WERE NO DELAYS IN THE INITIAL PROCEDURE AND NO OTHER PRODUCTS UTILIZED DURING THE INITIAL PROCEDURE. PATIENT RETURNED TO OFFICE ON (B)(6) 2024 FOR SUTURE REMOVAL. DURING THIS APPOINTMENT, THE PATIENT REPORTED MILD TO MODERATE TENDERNESS OF TISSUES AND SLIGHT BITING PRESSURE TENDERNESS. THE PATIENT'S DOCTOR RECOMMENDED A FOLLOW UP IN 6 WEEKS AND RECOMMENDED FLOSSING IN THAT AREA 3-5 DAYS. CUSTOMER STATED "ONE DAY AFTER LEAVING" (EXACT DATE NOT SPECIFIED AND IT WAS NOT SPECIFIED AFTER WHICH APPOINTMENT), THE PATIENT EXPERIENCED AN ALLERGIC REACTION AND DEVELOPED A RASH ON THE BELLY. THE PATIENT'S HANDS WERE ALSO ITCHY AND SWOLLEN. PATIENT'S PRIMARY CARE DOCTOR DIAGNOSED THE ISSUE AS INFLAMMATION IN THE BLOOD STREAM. PATIENT WAS PRESCRIBED DOXYCYCLINE, BUT AFTER FINISHING THE MEDICATION, THE RASH RETURNED. PATIENT WAS THEN PRESCRIBED AN ANTIHISTAMINE - RASH WAS "A LITTLE BETTER BUT NOT RESOLVED." PATIENT WAS GIVEN MEDROL DOSE PACK AND AFTER FINISHING, THE ITCHINESS AND RASH CAME BACK. IT WAS ALSO NOTED THE PATIENT HAS ALSO HAD TWO ROUNDS OF STEROIDS HOWEVER THE ITCHING PERSISTS AND "NOW INCLUDES HER FEET." THE PATIENT HAS SEEN THEIR ALLERGIST. FURTHER INFORMATION ON PATIENT STATUS WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498136 GIBSON HEALTHCARE BONE GRAFT PLUG SYNOSS COLLAGEN SYNTHETIC MINERAL - COLLAGEN BONE GRAFT MATRIX LYC COLLAGEN MATRIX, INC. 5824-413

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other