MAUDE Adverse Event Report: SICAT GMBH & CO. KG SICAT CLASSICGUIDE; SURGICAL GUIDE

Model Number 10301

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Perforation (2001)

Event Date 12/16/2022

Event Type  Injury  

Event Description

The reporting dentist has used a sicat surgical guide (sicat classicguide) for preparing osteotomies (drill holes for accommodating a dental implant) for dental implants.However, the implant (tooth #11) did not end up at the correct position and orientation.The dentist removed the implant and grafted the site and will let it heal.

Manufacturer Narrative

The following scenario appears to be the most probable: the planned implant position #11(23) does not seem to be completely surrounded by bone at the palatal and seems to be placed in an area of oblique bone structure.The drill probably slid at the bone structure and changed the drilling direction.This occured because the dentist did not press the surgical guide sufficiently tight onto the teeth during surgery.

• Brand Name: SICAT CLASSICGUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): SICAT GMBH & CO. KG; friesdorfer strasse 131-135; bonn, 53175 ; GM 53175
• Manufacturer Contact: manfred breuer ; friesdorfer strasse 131-135; bonn, nrw 53175 ; GM 53175
• MDR Report Key: 16130897
• MDR Text Key: 307013985
• Report Number: 3006098230-2022-00001
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA#S-P#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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10301
• Device Catalogue Number: 1030110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DENT. IMPL. SWEDEN&MARTINA OUT-LINK2 E2-ZT-330-115.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White