BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT Ø2.9MM SC, SLACTIVE® 14MM, RXD, LOXI

    MDR report key: 8016545 · Received October 29, 2018

    Report

    Report Number
    1222315-2015-00621
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    October 5, 2015
    Report Date
    October 24, 2018
    Manufacturer
    STRAUMANN USA, LLC
    Product Code
    DZE
    UDI-DI
    07630031728029
    PMA / PMN Number
    K162890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 REMOVAL OF A DENTAL IMPLANT DURING SURGERY WITHOUT THE REPLACEMENT OF ANOTHER DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE DUE TO EITHER LACK OF PRIMARY STABILITY OF THE IMPLANT (PATIENT OR PROCEDURE RELATED). IT MAY ALSO INCLUDE THE REMOVAL OF AN IMPLANT AFTER OSSEOINTEGRATION DUE TO EITHER THE CLINICIAN'S OR PATIENT'S DECISION. THE MANUFACTURER'S TREND ANALYSIS CONFIRMS.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT ON THE DAY OF THE DENTAL IMPLANT WAS PLACED, A FAILURE OCCURRED UPON INSERTION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857571 BLT Ø2.9MM SC, SLACTIVE® 14MM, RXD, LOXI ENDOSSEOUS DENTAL IMPLANT DZE STRAUMANN USA, LLC NA NN022 07630031728029

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention