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

Catalog Number 37503

Device Problems Malposition of Device (2616); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

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.In the order remarks the customer was informed about an uncertain matching and simulated extraction which could influence fit of the guide and the transfer of the implants.The preliminary investigation results point out that the simplant guide was designed according to specifications based on the clinical data provided by the customer.It was reported that a patient experienced a dental implant loss.Therefore, because a serious injury resulted, 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 safe guide to create the osteotomy for implant sites 12, 13 and 15 in combination with the astra tech surgery kit.The customer placed the implants with the simplant guide.All the implants are placed 1-2mm too buccal and the premolar implants fenestrated the buccal plate.The simplant guide fit fine on the teeth.The customer had to bone graft to correct the surgery.

Manufacturer Narrative

Guide is rocking on model because material on model is not removed to fit tube of implant 12.There is a tube stick out at this position which is less then 1mm (no remark needed).Planning of the implants is correct and guide is designed correctly.Produced guide is the same as digital guide.Post-op image shows the implants are not transferred as planned.

• 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.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12631169
• MDR Text Key: 276356709
• Report Number: 3007362683-2021-00008
• 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: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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: 37503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention