MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) SURGIGUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37504

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

Investigation has shown that the physical guide is manufactured correctly and according to the plan.Nothing in the information at hand suggests that the bone loss is caused by the dentsply sirona products used but rather by inadequate planning of the surgery.This event is reportable per 21 cfr part 803.

Event Description

According to the available information a patient received four astratech implants on (b)(6) 2019 in positions 4, 7, 11 and 13 (fdi # 15, 12, 23 and 25).The implants were placed with guided surgery using a mucosa supported simplant safe guide.Three months after surgery the patient came to the dentists office.Increased mobility of the prosthetic construction was noticed.X-rays showed substantial bone loss around the implants.A cone beam scan was performed showing buccal fenestration of the buccal cortex at implants 15 and 12.The planning of the surgery has been performed by the customer.Order remarks were provided to the customer that implant 15 is planned outside the bone and implant 24 is placed partially outside the bone, implant 12 is placed close to the incisive canal and no fixation screws are planned.The customer was advised to revise the plan.No changes are made and the guide was manufactured according to the plan.

• Brand Name: SURGIGUIDE
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, vastra gotalands lan [se-14] S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, pa ; 8494424
• MDR Report Key: 9776042
• MDR Text Key: 189495175
• Report Number: 9612468-2020-00040
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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