BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM

    MDR report key: 4206915 · Received October 28, 2014

    Report

    Report Number
    0001038806-2014-00130
    Event Type
    Injury
    Date Received
    October 28, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK122300
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED COMPONENT, A T3® NON-PLATFORM SWITCHED TAPERED IMPLANT ((B)(4)), HAS CONFIRMED THE FOLLOWING: THERE WAS NO DAMAGE NOTED TO THE INTERNAL HEX OF THE IMPLANT. NO DAMAGE WAS NOTED TO THE THREADS ON THE IMPLANT. A VISUAL COMPARISON OF THE RETURNED PRODUCT TO THE COMPONENT DRAWING ((B)(4) REV C) DID NOT INDICATE A MANUFACTURING DEFECT THAT WOULD CONTRIBUTE TO THIS EVENT. NO NON-CONFORMANCES WERE INITIATED FOR THE SUBJECT LOT. ALL UNITS FROM THIS LOT HAVE BEEN SHIPPED. THE REVIEW OF THE DHR RECORDS DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CONTRIBUTE TO THIS EVENT. LOT 1116764 UTILIZED COMMERCIALLY PURE (CP) TI FROM LOT 287342. A REVIEW OF THE RECEIVING INSPECTION AND CERTIFICATE OF ANALYSIS (COFA) FROM THE MANUFACTURER DID NOT IDENTIFY ANY DEVIATIONS WITH THE MATERIAL WHICH WOULD RESULT IN OR CONTRIBUTE TO THIS COMPLAINT. THE BIOCOMPATIBILITY ASSESSMENT CONCLUDED THAT THE SUBJECT COMPLAINT IMPLANT ITEM WAS BIOCOMPATIBLE BASED ON HISTORICAL USE OR STANDARDS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO MANUFACTURING DEVIATIONS WHICH WOULD HAVE RESULTED IN OR CONTRIBUTED TO THIS EVENT. ADDITIONALLY, THERE WERE NO ANOMALIES IDENTIFIED WITH THE RAW TI MATERIAL USED TO MANUFACTURE THE SUBJECT LOT.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE IMPLANT HAD TO BE REMOVED DUE TO AN ALLERGIC REACTION AND PRE- EXISTING LUNG PROBLEMS. THE DOCTOR REMOVED THE TITANIUM IMPLANT AND PLACED A ZIRCONIA IMPLANT INSTEAD. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690642 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I N/A 1116764

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention