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

Catalog Number 1030110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paresthesia (4421)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

The following scenario appears to be the most probable: the dentist planned implant at tooth #21 in a way, so that after surgery the implant ends up very close to the nerve canal of the nervus mandibularis.This may have caused the nerve to be compressed, resulting in the paresthesia.

Event Description

The reporting dentist has used a sicat surgical guide (sicat classicguide) for preparing osteotomies (drill holes for accommodating dental implants) for dental implants.However, the implants at position #21 and #28 did not end up at precisely the correct positon.The patient experienced paresthesia.The implant at position #21 had to be removed.

• 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: 12266591
• MDR Text Key: 264719882
• Report Number: 3006098230-2021-00003
• Device Sequence Number: 1
• Product Code: NDP
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1030110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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: BIOMET 3I(IFNT) DENTAL IMPLANT, SN: (B)(4).
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR