MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 4 IMPLANTS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37504

Device Problems Crack (1135); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Return of the guide is requested and product will be evaluated after receipt.At this moment no additional information is available as to what exactly happened and whether or how these events are related.After receipt of additional information and after the investigation is done an follow-up will be submitted.

Event Description

It was reported, that during a guided surgery 3 out of 4 implants could be placed as planned, but the 4th was swallowed by the patient.The customer also claimed that the guide was fractured.

Manufacturer Narrative

The investigation of the digital files and the returned material show that due to incorrect design the thickness of the resin below the irrigation hole was less than 1,5 mm.This can contribute to the crack near the guide sleeve # 12.The fit of the returned guide was good on the printed model.Corrected catalog #.

• Brand Name: SURGIGUIDE - 4 IMPLANTS
• 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: 17225496
• MDR Text Key: 318094597
• Report Number: 3007362683-2023-00033
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 08/02/2023

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: 37504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/28/2023
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other