BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø2.9MM SC, SLACTIVE® 12MM, RXD, LOXI

    MDR report key: 7996013 · Received October 23, 2018

    Report

    Report Number
    1222315-2018-00615
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    September 20, 2018
    Report Date
    October 19, 2018
    Manufacturer
    STRAUMANN USA, LLC
    Product Code
    DZE
    UDI-DI
    07630031728012
    PMA / PMN Number
    K162890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 CLINICAL 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 TWO MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN FDI SITE #13 OF THE PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837432 BLT Ø2.9MM SC, SLACTIVE® 12MM, RXD, LOXI ENDOSSEOUS DENTAL IMPLANT DZE STRAUMANN USA, LLC NA MH182 07630031728012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention