BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLX Ø3.5 RB, SLACTIVE® 10MM, RXD

    MDR report key: 22321454 · Received June 24, 2025

    Report

    Report Number
    0009613348-2025-009287
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 25, 2025
    Report Date
    October 17, 2025
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031743282
    PMA / PMN Number
    K191256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH NUMBER COULD NOT BE VERIFIED DUE TO INCOMPLETE OR MISSING INFORMATION AND / OR PRODUCT FROM THE CUSTOMER. 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: 1. ABSENCE OF PERSISTENT SUBJECTIVE COMPLAINTS SUCH AS PAIN, FOREIGN BODY SENSATION AND /OR DYSESTHESIA. 2. ABSENCE OF A RECURRENT PERI-IMPLANT INFECTION WITH SUPPURATION. 3. ABSENCE OF IMPLANT MOBILITY. 4. 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.

    Additional Manufacturer Narrative · 0

    THE BATCH NUMBER COULD NOT BE VERIFIED DUE TO INCOMPLETE OR MISSING INFORMATION AND / OR PRODUCT FROM THE CUSTOMER. 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: 1. ABSENCE OF PERSISTENT SUBJECTIVE COMPLAINTS SUCH AS PAIN, FOREIGN BODY SENSATION AND /OR DYSESTHESIA 2. ABSENCE OF A RECURRENT PERI-IMPLANT INFECTION WITH SUPPURATION 3. ABSENCE OF IMPLANT MOBILITY 4. 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. NON-FATAL SERIOUS INJURY OR DEVICE MALFUNCTION STORED DUE TO COVID 19 PANDEMIC IN ACCORDANCE WITH FDA GUIDANCE "POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC" PUBLISHED MAY 2020.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 24. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 24. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063958 BLX Ø3.5 RB, SLACTIVE® 10MM, RXD ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG 07630031743282

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention