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

Catalog Number 37504

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The clinician used a simplant pilot guide - longstop drill system to create the osteotomy for implant sites 36, 37, 43 and 45 in combination with the longstop drill kit.The customer placed the implants 43 and 45 with the simplant guide.He didn't use the simplant guide to place implants 36 and 37 because the pc was not in contact with the mucosa.A new surgery has been scheduled to place implants 36 and 37.We are waiting to receive the products back for complete investigating.So far, the preliminary investigation could only be performed on the digital design files.The digital design of the product does not show any abnormalities.The matching of the stone model in the ct-images was optimized by the design team.Due to the shape of the model the soft tissue near implant sites 36 and 37 doesn't look realistic which causes the issue that there is no contact between the simplant guide and mucosa.In the order remarks the customer was not informed about any issue concerning the matching of the plaster model in the ct-images.The design team should have warned for an uncertain matching of the stone model.It was maybe even better to place this order on hold and ask for a new model with more realistic soft tissue near implants 36 and 37.

Manufacturer Narrative

The preliminary investigation results point out that the simplant guide was not designed according to specifications based on the clinical data provided by the customer.Once we receive the product in the manufacturing facility a physical investigation of the product will be conducted.This event is reportable per 21 cfr part 803.

Manufacturer Narrative

The dhr review and the investigation of the digital files show that during design the matching of the stone model into the ct-images near implant positions # 36 and 37 was not correct.No notification was sent to the customer during design about the issue.The produced guide was only used for the implantation of implants #43 and # 45; the implantation of # 36 and 37 was not possible and the surgery was aborted and a second surgery is needed.

• 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
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12719274
• MDR Text Key: 282343301
• Report Number: 3007362683-2021-00009
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1