BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVABONE DENTAL PUTTY

    MDR report key: 7573084 · Received June 6, 2018

    Report

    Report Number
    3003768919-2018-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    September 15, 2017
    Report Date
    May 8, 2018
    Manufacturer
    NOVABONE PRODUCTS
    Product Code
    LYC
    UDI-DI
    00813909010366
    PMA / PMN Number
    K100671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A LOT NUMBER WAS NOT PROVIDED, NOVABONE HAS BEEN ABLE TO NARROW THE POSSIBLE SOURCE OF THE PRODUCT. THE PRODUCT IN QUESTION MOST LIKELY CAME FROM ONE OF THESE LOTS: LOT # 1607B7, LOT # 1607C1 , LOT # 1612B6 . DEVICE HISTORY RECORDS FOR THESE LOTS WERE PULLED AND REVIEWED. NO NONCONFORMANCES OR DEVIATIONS WERE ASSOCIATED WITH THESE LOTS. MANUFACTURING, STERILIZATION, AND DISTRIBUTION WERE ALL CONDUCTED ACCORDING TO SPECIFICATION. A REVIEW OF COMPLAINTS FROM THESE LOTS AND THIS PRODUCT SHOWED (B)(4) WAS RECEIVED FROM LOT 1607B7 WITH FAILURE MODE OF EMPTY CARTRIDGE. THERE WERE NO COMPLAINTS TO DATE FOR LOTS 1607C1 AND 1612B6. SINCE 2015, 32 COMPLAINTS HAVE BEEN RECEIVED FOR DENTAL BIOGLASS PRODUCTS WITH NO REPORTS OF INFLAMMATION OR INFECTION. THE 32 COMPLAINTS WERE LIMITED TO BROKEN CARTRIDGES AND HARD PUTTY, NO ADVERSE EVENTS. POST MARKET SURVEILLANCE FROM 2016 AND 2017 SUPPORT THE FOLLOWING CONCLUSIONS: THERE IS NO EVIDENCE OF QUALITY PROBLEMS ASSOCIATED WITH NOVABONE DEVICES. NO CORRECTIVE/PREVENTATIVE ACTION IS INDICATED. RESIDUAL RISKS ARE AS EXPECTED. NO NEW RISKS WERE IDENTIFIED. NOVABONE HAS IDENTIFIED THE POSSIBILITY OF INFLAMMATION AND REVISION SURGERY IN RISK ANALYSIS. WHILE INFLAMMATION CAN BE CAUSED BY NON-STERILE OR CONTAMINATED DEVICES, THE RECORDS REVIEW AND COMPLAINT HISTORY INDICATES THESE PRODUCTS WERE MANUFACTURED TO SPECIFICATION. THE LIKELIHOOD THAT THE NOVABONE DEVICE CONTRIBUTED TO THIS EVENT IS LOW WHEN COMPARED TO THE RISKS OF THE PROCEDURE ITSELF.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED INFLAMMATION, INFECTION, AND REMOVAL ON (B)(6) 2017. THE PART WAS NOT RETURNED AND THE EVENT WAS REPORTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418801 NOVABONE DENTAL PUTTY NOVABONE DENTAL PUTTY LYC NOVABONE PRODUCTS EU3620 N/A 00813909010366

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R