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

Catalog Number 37502

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

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

The clinician used a simplant universal guide to create the osteotomy for implants on tooth positions 19 and 20 in combination with the universal guided surgery kit.Afterwards the clinician placed implants free hand since a simplant universal guide does not provide implant placement control.After implant placement the clinician noticed that the lingual plate of the bone was perforated on both implant positions.The clinician left the implant on tooth position 19 in place although the implant was around 6-7mm off compared to the planned implant position according to the customer.The customer did add bone grafting to cover the bone fenestration.The implant on tooth position 20 has been removed during the same surgery and bone grafting was added to cover the bone fenestration.A second corrective surgery is necessary after the bone grafting is healed.The patient is fine and will recover completely according to the customer.

Manufacturer Narrative

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: 11031590
• MDR Text Key: 222267110
• Report Number: 3007362683-2020-00003
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: NA#S-P#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: 03/31/2021

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: 37502
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention