BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø2.9MM SC, SLACTIVE® 10MM, RXD, LOXI

    MDR report key: 8016555 · Received October 29, 2018

    Report

    Report Number
    1222315-2018-00620
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    September 20, 2018
    Report Date
    October 24, 2018
    Manufacturer
    STRAUMANN USA, LLC
    Product Code
    DZE
    UDI-DI
    07630031728005
    PMA / PMN Number
    K162890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 LI...

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT 2 WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE #10 OF THE PATIENTS MOUTH THE IMPLANT FAILED TO OSSEOINTEGRATE. IT WAS REPORTED THAT THE PATIENT HAD TYPE II BONE QUALITY AND GOOD HYGIENE AROUND THE IMPLANT AS WELL AS PAIN AND INFECTION AT THE TIME OF THE EVENT. THE PRODUCT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855960 BLT Ø2.9MM SC, SLACTIVE® 10MM, RXD, LOXI ENDOSSEOUS DENTAL IMPLANT DZE STRAUMANN USA, LLC NA MY465 07630031728005

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention