BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GO DIRECT COLLAR

    MDR report key: 10468556 · Received August 28, 2020

    Report

    Report Number
    3001617766-2020-06245
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    July 9, 2020
    Report Date
    May 7, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    EIL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. UPDATED SECTION B4 FOR REPORT SUBMISSION DATE AND B6 TO REPORT DEVICE EVALUATION RESULTS. UPDATED D9 FOR DEVICE RETURN DATE, G1 FOR FOLLOW-UP REPORT SUBMITTER, G3 FOR AWARENESS DATE AND G6 FOR REPORT TYPE AND FOLLOW-UP NUMBER. UPDATED H2 FOR FOLLOW-UP TYPE, H3 FOR DEVICE EVALUATION STATUS AND H6 METHOD, RESULT AND CONCLUSION CODES. THIS COMPLAINT IS BEING SUBMITTED LATE DUE TO THE FURLOUGHS THAT RESULTED FROM THE GLOBAL PANDEMIC AND IS CAPTURED WITHIN DEVIATION 1412.

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT IS UNKNOWN. UDI NUMBER AND K NUMBER DO NOT APPLY TO THIS PRODUCT.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), WRONG IMPLANT WERE PLACED IN THE PATIENT'S MOUTH AND THERE WAS NO STABILITY. PATIENT EXPERIENCED NO INJURIES. A SECOND SURGERY IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933658 GO DIRECT COLLAR DENTAL COLLAR EIL IMPLANT DIRECT SYBRON MANUFACTURING LLC 161834

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention| S