BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEROSS BONE GRAFT PLUG

    MDR report key: 20128583 · Received September 3, 2024

    Report

    Report Number
    2249852-2024-00023
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    July 24, 2024
    Report Date
    September 17, 2024
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    LYC
    UDI-DI
    00813954025322
    PMA / PMN Number
    K083742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ADDITIONAL QUALITY CONTROL TESTING IS PENDING.

    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. QUALITY CONTROL TESTING OF RESERVE PRODUCT MET ACCEPTANCE CRITERIA FOR VISUAL INSPECTION, PH, AND FORMALDEHYDE RESIDUAL CONTENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE ZIMVIE REGENEROSS BONE PLUG WAS USED ON A PATIENT AFTER TOOTH #6 WAS EXTRACTED ON (B)(6) 2024. PATIENT EXHIBITED INFLAMMATION, PAIN AND SWEATING. REVISION SURGERY PERFORMED ON (B)(6) 2024 AND THE ZIMVIE BONE PLUG WAS EXTRACTED DURING THE REVISION PROCEDURE. BONE, PRF (PLATELET RICH FIBRIN) AND "A SMALL MEMBRANE" (NAME OF MEMBRANE NOT PROVIDED) WAS PLACED IN THE EXTRACTION SITE DURING THE REVISION PROCEDURE. CUSTOMER CONFIRMED THE PATIENT'S DENTAL IMPLANT PLACEMENT IS DELAYED. ADDITIONAL CLARIFICATION SURROUNDING THE EVENT AND FUTURE DENTAL IMPLANT SURGERY WAS REQUESTED BUT NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833319 REGENEROSS BONE GRAFT PLUG SYNTHETIC MINERAL COLLAGEN BONE GRAFT MATRIX LYC COLLAGEN MATRIX, INC. RGP1020 SMCPN220901 00813954025322

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention| O