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

Catalog Number 37501

Device Problems Unstable (1667); Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The clinician used a simplant safe guide, for an azento order, to create the osteotomy for implant on tooth position 13 in combination with the astra tech guided surgery kit.The clinician noticed that there was no primary stability for the implant when torquing the implant.The implant site was regrafted and a new order will be placed in three months after healing.

Manufacturer Narrative

Guide received broken, unable to investigate.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: 11944691
• MDR Text Key: 254478432
• Report Number: 3007362683-2021-00001
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention