BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 10MM

    MDR report key: 7915423 · Received September 27, 2018

    Report

    Report Number
    0001038806-2018-00848
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    May 31, 2018
    Report Date
    October 16, 2018
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK122300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT: (B)(4). NO DEVICE WAS RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: BIOMET 3I DENTAL IMPLANT IFU (P-IIS086GI) REV F 11/2015 ALL DENTAL IMPLANTS ARE SUPPLIED STERILE AND ARE LABELED ¿STERILE¿. ALL PRODUCTS SOLD STERILE ARE FOR SINGLE-USE BEFORE THE EXPIRATION DATE PRINTED ON THE PRODUCT LABEL. DO NOT USE STERILE PRODUCTS IF THE PACKAGING HAS BEEN DAMAGED OR PREVIOUSLY OPENED. DO NOT RESTERILIZE. STORAGE AND HANDLING: DEVICES SHOULD BE STORED AT ROOM TEMPERATURE. REFER TO INDIVIDUAL PRODUCT LABELS AND THE SURGICAL MANUAL FOR SPECIAL STORAGE OR HANDLING CONDITIONS. REVIEW OF THE IMPLANT DHR DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING NONCONFORMITIES/DEVIATION OR MATERIAL DEFICIENCIES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. X-RAYS WERE PROVIDED FROM THE CUSTOMER. VISUAL INSPECTION OF THE X-RAYS IDENTIFIED THAT NEITHER THE IMPRESSION COPINGS NOR THE HEALING ABUTMENTS FULLY ENGAGED ONTO THE IMPLANT. THERE WAS A NOTICEABLE GAP BETWEEN THE IMPLANT PLATFORM AND THE POST. HOWEVER, ONE OF THE IMPRESSION COPINGS COMPLETELY ENGAGED ONTO THE IMPLANT AS INTENDED (SEE BELOW). ALTHOUGH THE CUSTOMER STATED THAT IT WAS A 3.4 MM IMPRESSION COPING, THE EXACT DETAILS COULD NOT BE VERIFIED BASED ON THE X-RAYS. PHOTOGRAPH OF THE IMPLANT LABEL STATED THAT THE IMPLANT IS A 4.1MM 3I T3 NON-PLATFORM SWITCHED TAPERED IMPLANT (BOST410). ALSO, THE PHOTOGRAPH OF THE IMPLANT IN THE OSTEOTOMY IDENTIFIED A BLUE COLORED PLATFORM RESEMBLING A BOST410 IMPLANT. IN ADDITION, THE X-RAYS OF THE IMPLANT IN THE OSTEOTOMY RESEMBLE THE DESIGN (DRAWING NO. 1040023 REV C) OF A BOST410 IMPLANT. THE ANGLED SURFACE BETWEEN THE COLLAR AND THE FIRST THREAD IS SIMILAR TO THAT OF THE BOST410 IMPLANT. THE 3.4 MM IMPLANTS DO NOT HAVE THAT FEATURE AS EVIDENT IN DRAWING NO. 1040021 REV C. THEREFORE, BASED ON THE INFORMATION PROVIDED, IT CAN BE CONFIRMED THAT THE IMPLANT IS A 4.1 MM BOST410 AS STATED IN THE LABEL. THE COMPLAINT WAS UNCONFIRMED, AS THE IMPLANT WAS IDENTIFIED TO BE A BOST410 AS STATED IN THE LABEL. THE PHOTOGRAPHS AND THE X-RAYS OF THE IMPLANT RESEMBLED A 4.1 MM BOST410 IMPLANT. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WITH THE IMPLANT LOT THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE ACTUAL DETAILS OF THE DEVICE USAGE ARE UNKNOWN. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SINGULAR CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED THAT DURING THE IMPRESSION PHASE OF THE IMPLANT RESTORATION, THE DOCTOR NOTICED THAT 4.1 MM COMPONENTS DID NOT ENGAGE PROPERLY WITH THE 4.0MM CERTAIN IMPLANT. A NEW 4.1MM CERTAIN IMPRESSION COPING WAS ALSO TRIED AND WOULD NOT SEAT EITHER. THE DOCTOR INDICATED THAT THERE WAS NOT BONE OR SOFT TISSUE OBSTRUCTION INSIDE THE IMPLANT. THE SALES REPRESENTATIVE SENT THE CLINICIAN A .4 MM IMPRESSION COPING AND HEALING ABUTMENT, AND PATIENT WAS RESCHEDULED ON 12 SEP 18 FOR A NEW IMPRESSION APPOINTMENT. ACCORDING TO THE CLINICIAN THE 3.4 MM COMPONENTS FIT PROPERLY WITH THE IMPLANT. THE CLINICIAN IS REPORTING THAT THE LABELING OF THE IMPLANT PACKAGING DOES NOT MATCH THE DIAMETER OF THE DEVICE THAT WAS PACKAGED WITH IN THE IMPLANT PACKAGING. DELAY IN PROCEDURE OF 5-5 HOURS. TOOTH LOCATION 25.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER, THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT DURING THE IMPRESSION PHASE OF THE IMPLANT RESTORATION, THE DOCTOR NOTICED THAT 4.1 MM COMPONENTS DID NOT ENGAGE PROPERLY WITH THE 4.0MM CERTAIN IMPLANT. A NEW 4.1MM CERTAIN IMPRESSION COPING WAS ALSO TRIED AND WOULD NOT SEAT EITHER. THE DOCTOR INDICATED THAT THERE WAS NOT BONE OR SOFT TISSUE OBSTRUCTION INSIDE THE IMPLANT. THE SALES REPRESENTATIVE SENT THE CLINICIAN A .4 MM IMPRESSION COPING AND HEALING ABUTMENT, AND PATIENT WAS RESCHEDULED ON 12 SEP 18 FOR A NEW IMPRESSION APPOINTMENT. ACCORDING TO THE CLINICIAN THE 3.4 MM COMPONENTS FIT PROPERLY WITH THE IMPLANT. THE CLINICIAN IS REPORTING THAT THE LABELING OF THE IMPLANT PACKAGING DOES NOT MATCH THE DIAMETER OF THE DEVICE THAT WAS PACKAGED WITH IN THE IMPLANT PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756167 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 10MM DENTAL IMPLANT DZE BIOMET 3I 2017020649

    Patients

    Seq Age Sex Outcome Treatment
    1