MAUDE Adverse Event Report: SICAT GMBH & CO. KG SICAT ACCESSGUIDE; ENDODONTIC GUIDE; ACCESSORY TO DENTAL BUR

Catalog Number 1060110

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

The dentist suspected that two of the three endodontic guides were not manufactured according to prescription/planning.Before initial shipment of the guides to the dentist, the sleeve positions and orientations had been verified at sicat surgical guides lab using a coordinate measurement machine.The final protocol of this procedure has been reevaluated.The protocol does not show any relevant deviation of the actual sleeve positions and angulations within the guides compared to the doctors planning of sleeve position and angulation.The accessguides could not be evaluated.The dentist had already deposed of the guides.(b)(4).

Event Description

The reporting dentist has used a sicat acessguide for preparing access canals for three root canals for tooth #19.Drilling the access canal went well for the first canal.However, the drillings for two mesial canals both perforated the furcation of tooth #19.The tooth prognosis is hopeless.The tooth has to be removed due to the perforation.Remark: the sicat acessguide consists of three separate guides, one guide for each access canal.

• Brand Name: SICAT ACCESSGUIDE
• Type of Device: ENDODONTIC GUIDE; ACCESSORY TO DENTAL BUR
• Manufacturer (Section D): SICAT GMBH & CO. KG; brunnenallee 6; bonn, nrw 53177 ; GM 53177
• Manufacturer Contact: manfred breuer ; brunnenallee 6; bonn, nrw 53177 ; GM 53177
• MDR Report Key: 8539330
• MDR Text Key: 142736310
• Report Number: 3006098230-2019-00001
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1060110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEISINGER ENDO ACCESS BURS
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 79