BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAROOT ZIRCONIUM OXIDE DENTAL IMPLANT

    MDR report key: 11853819 · Received May 20, 2021

    Report

    Report Number
    3008808095-2021-00001
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 19, 2021
    Report Date
    April 29, 2021
    Manufacturer
    CERAROOT S.L.
    Product Code
    DZE
    UDI-DI
    08435453900232
    PMA / PMN Number
    K093595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) - INVESTIGATION: THE BATCH NUMBER COULD BE VERIFIED (DENTIST REPORTED WRONG LOT NUMBER 3870410319 INSTEAD OF LOT NO. 38701410319). OUR MANUFACTURING QUALITY SYSTEM ASSURES THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFIRM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED. THE INFECTION OF THE ENDOSSEOUS DENTAL IMPLANT DURING THE HEALING PHASE IS A KNOWN INHERENT RISK OF THE TREATMENT WITH DENTAL IMPLANTS. THE MANUFACTURER'S TREND ANALYSIS CONFIRMS THAT THE REPORTED EARLY FAILURE RATE ASSOCIATED WITH ITS DENTAL IMPLANT IS BELOW THE EXPECTED FAILURE RATE FOR THIS TREATMENT AS PUBLISHED IN SCIENTIFIC LITERATURE. ANTIBIOTIC PRESCRIPTION IS CONSIDERED A USEFUL PROTOCOL IN PREVENTING INFECTION AFTER DENTAL IMPLANT SURGERY. THE DENTAL PROFESSIONAL SHOULD EVALUATE THE ORAL HYGIENE STATUS, THE AMOUNT OF SURGICAL TRAUMA, AND THE OVERALL PATIENT HEALTH IN ORDER TO DETERMINE THE NEED OR INDICATIONS OF SUCH PRESCRIPTION.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT INFECTION WAS DEVELOPED 7 DAYS POST SURGERY, THE DENTAL IMPLANT WAS REMOVED, AND ANTIBIOTIC WAS PRESCRIBED. DURING THE DENTAL IMPLANT PLACEMENT SURGERY THE IMPLANT WAS PLACED IMMEDIATELY AFTER TOOTH EXTRACTION IN THE SAME INTERVENTION. ANTIBIOTIC WAS NOT PRESCRIBED THE DAY OF SURGERY. PATIENT WAS HOSPITALIZED UNTIL INFECTION WAS RESOLVED AND THE PATIENT RETURNED HOME WITHOUT ANY FURTHER PROBLEMS, INJURIES OR COMPLICATIONS. THE IMPLANT SITE WILL BE LET TO HEAL UNTIL A NEW IMPLANT CAN BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753225 CERAROOT ZIRCONIUM OXIDE DENTAL IMPLANT CERAROOT CERAMIC IMPLANT DZE CERAROOT S.L. 160.012 38701410319 08435453900232

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization