BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3I T3® TAPERED IMPLANT 6/5 X 11.5MM

    MDR report key: 7588738 · Received June 11, 2018

    Report

    Report Number
    0001038806-2018-00596
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 15, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK122300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3 TAPERED IMPLANT WAS RETURNED FOR INSPECTION. VISUAL INSPECTION REVEALED SIGNIFICANT DAMAGE TO THE COLLAR AND DRIVE FEATURE OF THE IMPLANT. THE IMPLANT WAS FUNCTIONALLY TESTED WITH THE RETURNED DRIVERS AND IN-HOUSE DRIVERS, AND IT WAS DISCOVERED THAT NEITHER DRIVER COULD ASSEMBLE DUE TO THE INTERNAL IMPLANT DAMAGE. HOWEVER, THE IMPLANT DID MATCH PRINT SPECIFICATIONS FOR DRAWING NO 1040011 REV C. THE RETURNED DRIVERS WERE FUNCTIONALLY TESTED AS WELL. THEY DID NOT ASSEMBLE WITH AN IN-HOUSE IMPLANT AS BOTH DRIVERS WERE WORN. THE IMRE200 DID NOT HAVE AN O-RING EITHER. THE COMPLAINT IS CONFIRMED. 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: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR). BIOMET 3I DENTAL IMPLANT IFU (P-IIS086GI) REV F. INFORMATION IDENTIFIED: WARNINGS: EXCESSIVE BONE LOSS OR BREAKAGE OF A DENTAL IMPLANT MAY OCCUR WHEN AN IMPLANT IS LOADED BEYOND ITS FUNCTIONAL CAPABILITY. PHYSIOLOGICAL AND ANATOMICAL CONDITIONS MAY AFFECT THE PERFORMANCE OF DENTAL IMPLANTS. MISHANDLING OF SMALL COMPONENTS INSIDE THE PATIENT¿S MOUTH CARRIES A RISK OF INGESTION, ASPIRATION AND/OR SWALLOWING. FORCING THE IMPLANT INTO THE OSTEOTOMY DEEPER THAN THE DEPTH ESTABLISHED BY THE DRILLS CAN RESULT IN DAMAGE TO THE IMPLANT, DRIVER, OR OSTEOTOMY. FOR SHORT IMPLANTS, CLINICIANS SHOULD CLOSELY MONITOR PATIENTS FOR ANY OF THE FOLLOWING CONDITIONS: PERI-IMPLANT BONE LOSS, CHANGES TO THE IMPLANT¿S RESPONSE TO PERCUSSION OR RADIOGRAPHIC CHANGES IN BONE-TO-IMPLANT CONTACT ALONG THE IMPLANT¿S LENGTH. IF THE IMPLANT SHOWS MOBILITY OR GREATER THAN 50% BONE LOSS, THE IMPLANT SHOULD BE EVALUATED FOR POSSIBLE REMOVAL. IF A CLINICIAN CHOOSES A SHORT IMPLANT, THEN THE CLINICIAN SHOULD CONSIDER A TWO-STAGE SURGICAL APPROACH, SPLINTING A SHORT IMPLANT TO AN ADDITIONAL IMPLANT, AND PLACEMENT OF THE WIDEST POSSIBLE FIXTURE. IN ADDITION, THE CLINICIAN SHOULD ALLOW LONGER PERIODS FOR OSSEOINTEGRATION AND AVOID IMMEDIATE LOADING. REUSE OF BIOMET 3I PRODUCTS THAT ARE LABELED FOR SINGLE-USE MAY RESULT IN PRODUCT CONTAMINATION, PATIENT INFECTION AND/OR FAILURE OF THE DEVICE TO PERFORM AS INTENDED. PRECAUTIONS: THESE DEVICES ARE ONLY TO BE USED BY TRAINED PROFESSIONALS. THE SURGICAL AND RESTORATIVE TECHNIQUES REQUIRED TO PROPERLY UTILIZE THESE DEVICES ARE HIGHLY SPECIALIZED AND COMPLEX PROCEDURES. IMPROPER TECHNIQUE CAN LEAD TO IMPLANT FAILURE, LOSS OF SUPPORTING BONE, RESTORATION FRACTURE, SCREW LOOSENING INGESTION, ASPIRATION AND/OR SWALLOWING. WHEN THE CLINICIAN HAS DETERMINED ADEQUATE PRIMARY STABILITY IS ACHIEVED, IMMEDIATE FUNCTIONAL LOADING CAN BE CONSIDERED. THE FOLLOWING SHOULD BE TAKEN INTO CONSIDERATION WHEN PLACING DENTAL IMPLANTS: BONE QUALITY, ORAL HYGIENE, AND MEDICAL CONDITIONS SUCH AS BLOOD DISORDERS OR UNCONTROLLED HORMONAL CONDITIONS. THE HEALING PERIOD VARIES DEPENDING ON THE QUALITY OF THE BONE AT THE IMPLANTATION SITE, THE TISSUE RESPONSE TO THE IMPLANTED DEVICE AND THE SURGEON¿S EVALUATION OF THE PATIENT¿S BONE DENSITY AT THE TIME OF THE SURGICAL PROCEDURE. PROPER OCCLUSION SHOULD BE EVALUATED ON THE IMPLANT RESTORATION TO AVOID EXCESSIVE FORCE DURING THE HEALING PERIOD ON THE IMPLANT. IT IS RECOMMENDED THAT IMPLANTS LESS THAN 4 MM DIAMETER NOT BE PLACED IN THE POSTERIOR REGIONS. POTENTIAL ADVERSE EVENTS: POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF DENTAL IMPLANTS MAY INCLUDE: FAILURE TO INTEGRATE, LOSS OF INTEGRATION, DEHISCENCE REQUIRING BONE GRAFTING, PERFORATION OF THE MAXILLARY SINUS, INFERIOR BORDER, LINGUAL PLATE, LABIAL PLATE, INFERIOR ALVEOLAR CANAL, OR GINGIVA, INFECTION AS REPORTED BY ABSCESS, FISTULA, SUPPURATION, INFLAMMATION, OR RADIOLUCENCY, PERSISTENT PAIN, NUMBNESS, PARESTHESIA, HYPERPLASIA, EXCESSIVE BONE LOSS REQUIRING INTERVENTION, IMPLANT BREAKAGE OR FRACTURE, SYSTEMIC INFECTION, NERVE INJURY, INGESTION, ASPIRATION AND/OR SWALLOWING. COMPLAINT INDICATES DAMAGE OF THE INTERNAL HEX OF THE IMPLANT AND WEAR OF INSTRUMENTS THAT WERE USED TO PLACE THE IMPLANT THE ALLEGED EVENT WAS CONFIRMED DURING INSPECTION. A ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL HEX OF THE IMPLANT (BOPT6511) WAS DAMAGED. THE IMPLANT WAS REMOVED AND REPLACED IN THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428622 3I T3® TAPERED IMPLANT 6/5 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2016070007

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR