BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIM Ø4.1MM RD, ZLA 8MM, AH4MM, ZRO2

    MDR report key: 9160000 · Received October 5, 2019

    Report

    Report Number
    1222315-2019-09135
    Event Type
    Injury
    Date Received
    October 5, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 25, 2019
    Manufacturer
    STRAUMANN USA, LLC
    Product Code
    DZE
    UDI-DI
    07630031713872
    PMA / PMN Number
    K171769
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH NUMBER COULD BE VERIFIED. OUR MANUFACTURING Q-SYSTEM ASSURES, THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFIRM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED. THE NON-INTEGRATION OF AN ENDOSSEOUS DENTAL IMPLANT DURING THE HEALING PHASE IS A KNOWN INHERENT RISK OF THE TREATMENT WITH DENTAL IMPLANTS. MOST IMPLANT FAILURES OCCUR BEFORE OCCLUSAL LOADING (ANALAINEN ET AL. 2013, KOLDSLAND ET AL. 2009). BASED ON CLINICIAL STUDIES ABOUT 1-3% OF THE IMPLANTS FAIL WITHIN THE FIRST YEAR AFTER IMPLANTATION (GANELES ET AL. 2008). IMPLANTS MAY HAVE TO BE REMOVED IN CASE ONE OR MORE OF THE IMPLANT SUCCESS CRITERIA ARE NOT MET. IMPLANT SUCCESS CRITERIA ACCORDING TO BUSER ET AL. (1991) ARE: ABSENCE OF PERSISTENT SUBJECTIVE COMPLAINTS SUCH AS PAIN, FOREIGN BODY SENSATION AND /OR DISESTHESIA. ABSENCE OF A RECURRENT PERI-IMPLANT INFECTION WITH SUPPURATION ABSENCE OF IMPLANT MOBILITY. ABSENCE OF A CONTINUOUS RADIOLUCENCY AROUND THE IMPLANT. THE MANUFACTURER'S TREND ANALYSIS CONFIRMS THAT THE REPORTED EARLY FAILURE RATE ASSOCIATED WITH ITS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS TREATMENT AS PUBLISHED IN THE SCIENTIFIC LITERATURE.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT FIVE WEEKS AFTER THE DENTAL IMPLANT WAS PLACED, IN FDI SITE #15 OF THE PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953859 CIM Ø4.1MM RD, ZLA 8MM, AH4MM, ZRO2 ENDOSSEOUS DENTAL IMPLANT DZE STRAUMANN USA, LLC NA TA164 07630031713872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention