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

Catalog Number 37501

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Because a serious injury resulted, 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 19 in combination with the astra tech surgery kit.The customer complained about the implant transfer was too shallow and he felt the entire buccal wall implant was out of bone and he needed to graft the patient.No patient harm during surgery.Patient was grafted and is healing and may need additional grafting in the future to cover the implant.The guide seated on the patient ok.The investigation results point out that the simplant guide was designed according to specifications based on the approved implant planning by the customer.There is no indication found that the simplant guide could have negative impact on the primary stability of the implant.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Customer was informed about low bone volume situation at the beginning and asked to proceed.In the order remarks they were warned about this once again the design of the implant guide is correct, customer approved the first proposal which was made by the design team.

• 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: 13418298
• MDR Text Key: 286674043
• Report Number: 3007362683-2022-00001
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• 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