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 11/05/2018

Event Type  Injury  

Manufacturer Narrative

The dentist suspected that the two endodontic guides were not manufactured according to prescription/planning.The dentist has returned the suspected sicat accessguide(s) back to sicat for evaluation.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 returned sicat acessguide(s) were evaluated using a 3d printed model of the patients jaw.The seating of the guides is stable.The access holes are in the occlusion at the positions and angulations planned by the dentist.The inspection does not give any indication for an incorrect arrangement of the sleeves or of any other device problem.

Event Description

The reporting dentist has used a sicat acessguide for preparing access canals for two root canals of tooth #4.However, the drillings were more distal for the buccal canal than he planned and the access hole for the lingual canal was also too far distal.The root canal could not be found.The tooth had to be extracted.Remark: the sicat acessguide consists of two 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: 8124824
• MDR Text Key: 129060511
• Report Number: 3006098230-2018-00007
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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: 85 YR
• Patient Weight: 59