MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 1 IMPLANT; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 04/27/2022

Event Type  Injury  

Event Description

It was reported that a patient experienced a dental implant loss.Region 13 bone level was low and it was decided to perform sinus lift.During this operation it was noticed that the bone structure was much narrower than what was expected after cbct.The sinus lift was performed via lateral access without problems.As there was enough bone to stabilize the implant, the implant drilling was carried out immediately.The drilling itself had no problems, but the drill was guided too palatally, close to perforating the bone wall.When placing the implant, it felt as if it slipped palatally.Due to no primary stability, the implant was taken out in the same session.To widen the bone ridge, volumax was placed palatally and implant will be placed after 4-6 months.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.

• Brand Name: SURGIGUIDE - 1 IMPLANT
• 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 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 14630935
• MDR Text Key: 293527177
• Report Number: 3007362683-2022-00023
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNIQUE REFERENCE PER ORDER (CU
• Device Lot Number: 8228148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/03/2022
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 26322
• Patient Outcome(s): Required Intervention