MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SIMPLANT GUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37501

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

We are waiting to receive the products back for thorough investigating.Therefore the current investigation could only be performed on the digital design files.The matching of the tooth model onto the ct images is optimal to ensure a correct implant transfer.The surgical guideline provided with the simplant safe guide is specifying the correct drilling sequences.This indicates that the correct use of the surgical guideline would provide a proper implant transfer.In addition, the simplant guide tube positions are designed correctly.The digital findings point out that the simplant guide was manufactured according to specifications.The design of the guide is fully made in accordance to the preoperative plan created by the clinician.

Event Description

A clinician used a simplant safe guide to create the osteotomy for a dental implant on tooth position 4 using the nobel biocare guided surgery kit.The implant went more mesial, going into the sinus, during the surgery.The clinician will have to do a correction surgery.There is no further information available about the condition of the patient.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

• Brand Name: SIMPLANT GUIDE
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• MDR Report Key: 10486314
• MDR Text Key: 205466201
• Report Number: 3007362683-2020-00002
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention