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 Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Product return is requested and product will be evaluated after receipt.The investigation of the planning and production files did not reveal any conspicuities.In case any new or additional information will be gained from the investigation of the actual product a follow-up report will be sent.Trend is tracked and monitored.

Event Description

Surgiguide was used for an implant case, everything seemed fine until a look at the final x-ray.Apical portion of implant was far more mesial than anticipated.It came dangerously close to hitting adjacent tooth.Backed out the implant and had to regraft the area.Guide fit well in patient¿s mouth and on the model.The patient is fine and very understanding.It was reported that a patient experienced a dental implant loss.

• 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: 19086197
• MDR Text Key: 339879511
• Report Number: 3007362683-2024-00003
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/11/2024

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?: No
• Device Catalogue Number: UNIQUE REFERENCE PER ORDER (CU
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/20/2024
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2024
• Type of Device Usage: A
• Patient Sequence Number: 1