BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 11891202 · Received May 26, 2021

    Report

    Report Number
    3012787974-2021-80014
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 26, 2021
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K202100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. WITH REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTION OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. POSSIBLE CLINICAL FACTORS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT'S PRE-EXISTING DENTAL CARE HISTORY INCLUDING INDICATION FROM THE FIELD REPORT THAT THE CROWN WAS DETERIORATED PRIOR TO SPLINT PLACEMENT. THE NEOCIS GUIDANCE SYSTEM USER MANUAL CONTRAINDICATES FOR USE IN PATIENTS THAT HAVE INSUFFICIENT BONE OR TEETH TO RETAIN A NEOCIS CHAIRSIDE PATIENT SPLINT (CPS) RIGIDLY THROUGHOUT A SURGICAL PROCEDURE. ISSUES OF THIS NATURE WILL BE TRACKED AND TRENDED TO DETERMINE IF ADDITIONAL ESCALATION IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REMOVAL OF THE CHAIRSIDE PATIENT SPLINT (CPS) THAT THE PATIENT'S DECAYED NATURAL CROWN WAS REMOVED. NO FURTHER INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787224 NEOCIS GUIDANCE SYSTEM DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 N/A 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability