BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDOR

    MDR report key: 8243950 · Received January 14, 2019

    Report

    Report Number
    3004108559-2019-00001
    Event Type
    Injury
    Date Received
    January 14, 2019
    Date of Event
    June 1, 2018
    Report Date
    January 14, 2019
    Manufacturer
    DEGRADABLE SOLUTIONS AG
    Product Code
    LYC
    PMA / PMN Number
    K131385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST ORIGINAL REPORT WAS SENT TO FDA OVER FEDEX ON (B)(6) 2018 S. THIS IS AN ELECTRONIC VERSION. THE DENTIST WAS REPEATEDLY ASKED WHAT PERIODONTAL TREATMENT WAS MADE PRIOR TO THE IMPLANTATION AND WHAT THE PERIODONTAL STATUS WAS, LOT-NUMBER, WHETHER ONE OR BOTH TOOTH EXTRACTION SITES WERE AFFECTED ETC. NO REPLY TILL (B)(6). ROOT CAUSE: THE DEVICE DID NOT LIKELY CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT (THE DEVICE DID NOT FAIL, IS NOT IMPROPERLY OR INADEQUATELY DESIGNED OR MANUFACTURED AND WAS NOT SUBJECT TO USER ERROR DUE TO INADEQUATE LABELING). DUE TO THE LACK OF INFORMATION ABOUT THE LOT AN ARTICLE NUMBER THE DOCUMENTATION FROM ALL POSSIBLE LOTS WAS REVIEWED. NO DEVIATION WAS DISCOVERED. IT IS POSSIBLE THAT THE PERIODONTAL INFECTION WAS NOT COMPLETELY ELIMINATED PRIOR TO THE APPLICATION OF THE GRAFTING MATERIAL. IT IS ALSO POSSIBLE THEN USING BIOMATERIALS THAT DO NOT RESORB QUICKLY (SUCH AS BGS OR MEMBRANE) THAT A SMALL INFECTION CAN LINGER FOR OVER SEVERAL MONTHS UNTIL IT BREAKS OUT AND BECOMES APPARENT. ALSO IT CAN NOT BE EXCLUDED THAT THE INFECTION CAME FROM OUTSIDE DURING THE HEALING.

    Description of Event or Problem · 1

    THE DENTIST IN (B)(6) EXTRACTED TWO TEETH FROM SITES 33 AND 43 IN (B)(6) 2017 DUE TO A MODERATE PERIODONTAL BONE LOSS (INDICATES PRECEDING PERIODONTAL BONE LOSS INFECTION) AND APPLIED EASY-GRAFT CLASSIC FOR BONE GRAFTING. NO IMPLANTS WERE PLACED. ACCORDING TO THE DENTIST, THE SITES WERE NOT INFECTED/INFLAMED PRIOR TO THE APPLICATION OF EASY-GRAFT CLASSIC (PRODUCT GROUP C11, LOT-NUMBER CURRENTLY UNKNOWN). THE HEALING PROCESS WAS UNEVENTFULLY FOR 6 MONTHS, BUT THE PATIENT RECONSULTED THE DENTIST 8 MONTHS AFTER BONE GRAFTING WITH A SEVERE INFECTION (IT IS CURRENTLY UNKNOWN WHETHER ONE OR BOTH TOOTH-EXTRACTIONS SITES WERE AFFECTED). THE FIRST SYMPTOMS WERE REPORTED BY THE PATIENT IN (B)(6) 2018. THE DENTIST FOUND AN ABSCESS IN THE AREA OF THE GRAFTED SOCKET (S). THE PATIENT WAS HOSPITALIZED IN (B)(6) 2018. THEREFORE, THE EASY-GRAFT CLASSIC MATERIAL WAS REMOVED FROM THE SITE (S) AND DRAINS WERE APPLIED BY AN ORAL SURGEON. ACCORDING TO THE PROVIDED INFORMATION, THE PATIENT I CURRENTLY SYMPTOM-FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37983 GUIDOR EASY-GRAFT CLASSIC LYC DEGRADABLE SOLUTIONS AG C11 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization