BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEROSS

    MDR report key: 20637282 · Received November 8, 2024

    Report

    Report Number
    2249852-2024-00025
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    September 26, 2024
    Report Date
    November 7, 2024
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    LYC
    PMA / PMN Number
    K083742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 QUALITY ASSURANCE ASSESSMENT CONFIRMED THAT ALL PROCESSES ASSOCIATED WITH THE PRODUCT WERE REVIEWED AND MET ACCEPTANCE CRITERIA.

    Description of Event or Problem · 0

    CUSTOMER STATED A PATIENT UNDERWENT SURGICAL EXTRACTION OF TOOTH #2 AND TOOTH #31 ON (B)(6) 2024. THE REGENEROSS PRODUCT WAS USED. CUSTOMER CONFIRMED NO INFECTION WAS SEEN AT THE TIME OF INITIAL SURGERY AND NO PERIAPICAL PATHOLOGY WAS PRESENT. THE NEXT DAY, ON (B)(6) 2024, PATIENT REPORTED COLD SHIVERS, LETHARGIC, AND HAD A FEVER OF 100.5 DEGREES FAHRENHEIT. PATIENT WENT TO URGENT CARE (ON AN UNSPECIFIED DAY). PHYSICIAN FROM URGENT CARE CONFIRMED WITH THE CUSTOMER THE BONE GRAFT SITES "LOOKED FINE." PATIENT WAS TESTED FOR BLOOD CULTURES AND TESTED POSITIVE. PATIENT WAS ADMITTED TO THE HOSPITAL AS A RESULT OF THE POSITIVE BLOOD CULTURE AND WAS PROVIDED IV ANTIBIOTICS. THE PATIENT WAS DISCHARGED HOME ON ORAL ANITBIOTICS (LEVOFLOXACIN). ADDITIONAL INFORMATION SURROUNDING THE SPECIFIC DAY THE PATIENT WENT TO URGENT CARE, THE DAY THE PATIENT WAS DISCHARGED HOME, THE POSITIVE BLOOD CULTURE TEST, AND THE PATIENT'S CURRENT STATUS WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943503 REGENEROSS SYNOSS COLLAGEN SYNTHETIC MINERAL - COLLAGEN BONE GRAFT MATRIX LYC COLLAGEN MATRIX, INC. RGP1020 SMCN240202

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Other| H