BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY 3 IMPLANT

    MDR report key: 9081617 · Received September 18, 2019

    Report

    Report Number
    3001617766-2019-03737
    Event Type
    Injury
    Date Received
    September 18, 2019
    Date of Event
    August 17, 2019
    Report Date
    October 4, 2019
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307102397
    PMA / PMN Number
    K090234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION.

    Description of Event or Problem · 0

    REVIEWED ATTACHED CUSTOMER FEEDBACK FORM. CONTRAINDICATIONS RELEVANT TO FAILURE: PATIENT IS OVER 60 YEARS OLD. PART: 863210. REVISION: A. VISUAL: IMPLANT RECEIVED IS SLIGHTLY DAMAGED. SPECIFICATION SHOULD BE: LENGTH: .404 ± .003, SPECIFICATION AS FOUND: .4062, DIAMETER: .1250 / .1265, SPECIFICATION AS FOUND: .1250. COMMENTS: THIS IMPLANT WAS DAMAGED AROUND THE COLLAR AREA AT THE TIME IT WAS REMOVED FROM THE PATIENTS MOUTH. PERFORMED A VISUAL AND DIMENSIONAL INSPECTION ON THE PRODUCT RECEIVED AND IT MEETS OUR SPECIFICATIONS. DATE OF INSPECTION: 09/26/2019.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876232 LEGACY 3 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC 137212 10841307102397

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention