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

Catalog Number 1030120

Device Problem Device Handling Problem (3265)

Patient Problem Debris, Bone Shedding (1803)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

The dentist suspected that the surgical guide was not manufactured according to prescription/planning.The dentist has returned the suspected dental guide back to sicat for evaluation.Before initial shipment of the guide to the doctor, the sleeve position 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 position and angulation compared to the doctors planning of sleeve position and angulation.The returned surgical guide was evaluated using optical scans of the surgical guide and a plaster model of the patients jaw.A quantitative analysis of the overlays of optical scans and x-ray scans does not give an indication for an incorrect placement or angulation of the sleeve compared to the doctors planning.Probable cause of event: dentist inserted drill into sleeve when drill was already in rotation.Drill caused shedding of sleeve, which allowed for an incorrect angulation of the drill.

Event Description

The reporting dentist has used a sicat surgical guide (sicat optiguide) for preparing the osteotomies (drill hole for accommodating a dental implant) for two dental implants of type "implant direct, legacy3 sbm".With guide seated well, guide path for tooth number 26 was more to the distal (closer to tooth #27) than planned.While the dentist tried to correct the path in subsequent rounds he was unable and the final position of the implant was too distal.The implant was removed and osteotomy site grafted.He will have to return to the site in the future to place the implant.Tooth 23 went exactly as planned.The guide was seated exactly the same for each osteotomy.The dentist wants to know if the placement of the drill sleeve within the surgical guide for tooth 26 was off.

• Brand Name: SICAT OPTIGUIDE
• 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 ; 228854697
• MDR Report Key: 6275505
• MDR Text Key: 65670306
• Report Number: 3006098230-2017-00001
• 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: 01/25/2017

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: Dentist
• Device Catalogue Number: 1030120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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: IMPLANT DIRECT, LEGACY3 SBM (SERIAL NO. (B)(4))
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 50