BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    SP, 4.8MM WN, SLA 10MM

    MDR report key: 10530441 · Received September 14, 2020

    Report

    Report Number
    0009613348-2020-50522
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    May 22, 2020
    Report Date
    January 8, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    DZE
    UDI-DI
    07630031719195
    PMA / PMN Number
    K033922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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 FDI 27, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    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 FDI 27, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. PATIENT PRESENTED WITH BONE TYPE III AND FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995022 SP, 4.8MM WN, SLA 10MM ENDOSSEOUS DENTAL IMPLANT DZE INSTITUT STRAUMANN AG SLA TITANIUM TL NK952 07630031719195

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention