BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM

    MDR report key: 7330270 · Received March 12, 2018

    Report

    Report Number
    0001038806-2018-00203
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Report Date
    July 5, 2018
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK122300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO¿ TO ¿YES¿.

    Additional Manufacturer Narrative · 1

    ONE T3 TAPERED IMPLANT WAS RETURNED FOR INSPECTION. THE PRODUCT SHOWS SIGNIFICANT SIGNS OF TISSUE ATTACHMENT ABOUT THE THREADS AND COLLAR. THE INTERNAL DRIVE FEATURE SHOWS SIGNS OF WEAR CONSISTENT WITH USE. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: P-IIS086GI REV. F 11/2015 AND INSTSM REV D 02/16. INFORMATION IDENTIFIED: IFU (P-IIS086GI REV. F 11/2015) STATES, STERILITY: 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 RE-STERILIZE. COMPLAINT INDICATES THAT THE IMPLANT DID NOT MATCH PRINT SPECIFICATIONS FOR THE BOST510 IMPLANT, AND WAS SHORTER THAN EXPECTED. THE PRODUCT WAS MEASURED, AND FOUND TO MATCH PRINT SPECIFICATIONS AGAINST DRAWING 1040025 REV C, WHICH IS THE DRAWING CONSISTENT WITH THE BOST510 IMPLANT. THE COMPLAINT IS THEREFORE UNCONFIRMED. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED, AS NO DEFICIENCY WAS DETECTED FOLLOWING INSPECTION. (B)(4). DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO¿ TO ¿YES¿.

    Description of Event or Problem · 1

    DOCTOR INDICATES THEY ORDERED A BOST510 BUT UPON ACTUAL PLACEMENT OF THE IMPLANT SIZE IT WAS A 4X10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173887 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 10MM IMPLANT DZE BIOMET 3I 2016092173

    Patients

    Seq Age Sex Outcome Treatment
    1