MAUDE Adverse Event Report: NEOCIS INC. NEOCIS GUIDANCE SYSTEM; DENTAL STEREOTAXIC INSTRUMENT

Model Number GEN 1

Device Problem Protective Measures Problem (3015)

Patient Problem Tooth Fracture (2428)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

Fr(b)(4).Precipitating event: upon an attempt to secure the chairside patient splint (cps) using dental material, the cps was found to be loosely affixed to the patient.Upon removal of the cps, the physician noted that the tooth filing had been removed with the cps.(b)(4): serious injury event: the cps was rigidly affixed to the patient.The procedure was successfully completed.Upon removal of the cps after the procedure, the physician noted that a portion of an underlying tooth (#4) was removed with the cps.The patient was referred to a restorative dentist for repair of the damaged tooth.(b)(4).

Event Description

(b)(4).It was reported via a complaint ((b)(4)) during splint removal a portion of a tooth was removed with the splint.The patient had a history of a tooth cavity at the site.Prior to the tooth damage, it was further reported that while attempting to place the splint the cavity filling was removed from the same tooth ((b)(4)).The patient was referred to a restorative dentist to evaluate and repair the damaged tooth.No further patient complications or device issues were reported.

• Brand Name: NEOCIS GUIDANCE SYSTEM
• Type of Device: DENTAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NEOCIS INC.; 555 nw 29th st; miami FL 33127
• Manufacturer (Section G): NEOCIS INC.; 555 nw 29th st; miami FL 33127
• Manufacturer Contact: thomas claiborne ; 555 nw 29th st; miami, FL 33127
• MDR Report Key: 9333405
• MDR Text Key: 166775499
• Report Number: 3012787974-2019-80003
• Device Sequence Number: 1
• Product Code: PLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GEN 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR