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

Catalog Number 1030120

Device Problem Device Handling Problem (3265)

Patient Problem Perforation (2001)

Event Date 01/10/2017

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 surgical 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 within the surgical guide compared to the doctors planning of sleeve position and angulation.The returned surgical guide was evaluated using a 3d x-ray scan of the patient, an optical scan of the patients jaw and a plaster model of the patients jaw.A qualitative analysis shows inconsistencies between the x-ray scan, the optical scan and the plaster model.Probable cause of event: the 3d x-ray scan (to old) and/or the optical scan (deformed) that were used by the dentist for implant planning do not represent the actual dentition of the patient.As a result, the fit of the surgical guide was unstable.The guide should not have been used for surgery.

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 "blue sky bio max".He gave anesthetic and had to adjust teeth to get guide to seat properly.But still he was never able to find a stable position.He noticed that the guide seemed to pivot on tooth #11 and was unstable from there.He even tried holding it down in two places at the same time.He decided to proceed with surgery anyway.He did both osteotomies using blue sky bio components and inserted both implants using the proper tools and technique through the guide.He then did a check film and found that #14 implant was too close to the bone wall, from the coronal aspect and along the body towards the apex.#13 was placed as planned.He decided it was too risky for bone to leave #14 and so he removed the implant and placed heavy bone grafting.He will allow it to heal for a few months.Patient is recovering well and future implant should be possible.

• 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: 6314252
• MDR Text Key: 66926189
• Report Number: 3006098230-2017-00002
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• 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: BLUE SKY BIO MAX IMPLANT #IJH3508
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 50