BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® TAPERED IMPLANT 5/4 X 11.5MM

    MDR report key: 3994393 · Received August 8, 2014

    Report

    Report Number
    0001038806-2014-00097
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK122300
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: COMPLAINT INVESTIGATOR¿S VISUAL INSPECTION (MICROSCOPE 10X) OF RETURNED COMPONENT, 3I T3® TAPERED IMPLANT 5/4 X 11.5MM ((B)(4)) HAS CONFIRMED THE FOLLOWING: DAMAGED INTERNAL HEX; DEVICE APPEARS WELL USED AND WORN; DAMAGE TO THE INTERNAL THREADS OF THE IMPLANT. ALTHOUGH AN IN DEPTH DIMENSIONAL INSPECTION IS LIMITED DUE TO THE DAMAGED AS RETURNED PRODUCT, VISUAL INSPECTION IN COMPARISON WITH (B)(4) AND DHR REVIEW DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THAT THE IMPLANT WAS NOT ABLE TO BE TORQUED DUE TO INTERNAL DAMAGE TO THE IMPLANT (NO LONGER FUNCTIONAL). THE DOCTOR ALSO REPORTED THAT HE DID NOT WANT TO SUBJECT THE PATIENT TO ANY FURTHER TRAUMA, THE CASE WAS ABORTED (CLOSED THE SITE) AND RESCHEDULED FOR FUTURE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469797 3I T3® TAPERED IMPLANT 5/4 X 11.5MM 3I T3® TAPERED IMPLANT 5/4 X 11.5MM DZE BIOMET 3I N/A 20131005558

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention