BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERED IMPLANT DENSE BONE TAP 6 X 11.5MM

    MDR report key: 2120631 · Received June 10, 2011

    Report

    Report Number
    1038806-2011-00002
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    February 2, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BIOMET 3I
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    LIIKELY CAUSE: CLINICIAN DID NOT PROPERLY PREPARE OSTEOTOMY BEFORE USING TAP. THIS IS THE ONLY REPORTED INCIDENT TO DATE. ISOLATED.THE DHR DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CAUSE THIS CONDITION. THE MANUFACTURER ACKNOWLEDGES THAT THIS INCIDENT IS BEING FILED LATE. PREVIOUSLY, BASED UPON THE CLINICAL JUDGMENT OF AN OUTSIDE EXPERT DENTAL PRACTITIONER, BIOMET 3I DETERMINED THAT THE EVENT WAS NOT REPORTABLE. HOWEVER, AFTER FURTHER REVIEW AND FURTHER DISCUSSION WITH THE SAME OUTSIDE EXPERT, IT WAS DECIDED TO REPORT THE EVENT. THE INITIAL EVALUATION CONCLUDED THAT THIS EVENT WAS SOLELY RELATED TO DECISIONS MADE BY THE CLINICIAN PERFORMING THE PROCEDURE. FURTHER DISCUSSION SUPPORTED THIS CONCLUSION. HOWEVER, BIOMET 3I WISHES TO FILE.

    Description of Event or Problem · 1

    TAP BECAME STUCK IN SITE, STRIPPED THE TAP HEAD TRYING TO REMOVE THE TAP. TREPHINING WAS USED TO REMOVE THE TAP. THE SITE WAS GRAFTED, PATIENT WAS SENT HOME TO HEAL AND OSTEOTOMY PREPARATION/IMPLANT PLACEMENT WILL BE ATTEMPTED AGAIN IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED IMPLANT DENSE BONE TAP 6 X 11.5MM TAPERED IMPLANT DENSE BONE TAP 6 X 11.5MM HWX BIOMET 3I NTAP611 952621

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention