BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    BLT 4.8MM RC, SLA 10MM, TIZR, LOXIM

    MDR report key: 10803163 · Received November 6, 2020

    Report

    Report Number
    0009613348-2020-64063
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    September 22, 2020
    Report Date
    January 8, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031707543
    PMA / PMN Number
    K150938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    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 (PATIENOR 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 THAT USUALLY PROCEDURAL ERRORS AND/OR PATIENT'S CONDITION CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 30, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMMEDIATE EXTRACTION SITE. PATIENT PRESENTED WITH BONE TYPE IV, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    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 THAT USUALLY PROCEDURAL ERRORS AND/OR PATIENT'S CONDITION CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 30, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMMEDIATE EXTRACTION SITE. PATIENT PRESENTED WITH BONE TYPE IV, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262971 BLT 4.8MM RC, SLA 10MM, TIZR, LOXIM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA ROXOLID BL YR616 07630031707543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention