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

Catalog Number 1030110

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Device Handling Problem (3265)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

The analysis does not give any indication for a substantial malfunction or fault of the sicat classicguide as manufactured by sicat: the guide is representing the dentists planning and was manufactured according to the planning and prescription of the dentist.The sleeve position does not deviate significantly from the planned position and can therefore not be the reason for the problem.The drilling protocol is correct and cannot be the reason for the problem.The analysis supports the following scenario as being most probable: the surgical guide was not pushed down completely on the patient's jaw during surgery.This resulted in a remaining gap between guide an jaw, so the drill did not end up deep enough.However, an acrylic leftover on the guide from production might have added to the misfit.

Event Description

The reporting dentist has used a sicat surgical guide (sicat classicguide) for preparing the osteotomies (drill hole for accommodating a dental implant) for two dental implants of type "astratech implant system ev".On (b)(6) 2017, the dentist placed the implants using the surgical guide at sites ada #3 and ada #4.At his final osteotomy, he noticed the collar of the implant #3 was at the level of the gingiva which he felt wasn't deep enough according to his planning.He took an x-ray and saw the apex of the implant was still several mm from the sinus.The dentist chose to back out and remove the implant.He used a longer drill and placed the implant again.The dentist suspects, the drilling protocol provided by sicat with the guide might have been incorrect.On (b)(6) 2018 the dentist informed sicat, that the implant failed.He removed the implant and grafted #03 site heavily with bone and will allow to heal before attempting another implant in that site.The dentist thinks the implant failed because ist was contaminated during the procedure of removing and replacing.

• Brand Name: SICAT CLASSICGUIDE
• Type of Device: SURGICAL GUIDE
• 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: 7316103
• MDR Text Key: 101600220
• Report Number: 3006098230-2018-00002
• 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: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 1030110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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: ASTRATECH IMPLANT OS EV S, SER.# (B)(4), LENGTH 8MM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 54