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

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Sinus Perforation (2277)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.

Event Description

In this event a surgiguide was used in surgery.Mucosa supported guide with fixation pins was attached to the jaw, the fit was ok, 3 implants were placed fine only implant 25 not.Customer followed the drilling protocol and does not know what caused this issue, he sent the patient to the stomatologist who claims that no implant could be placed in that position.The stomatologist removed the implant and the patient is fine now.

• 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: 17877994
• MDR Text Key: 325006576
• Report Number: 3007362683-2023-00041
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/05/2023

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: UNIQUE REFERENCE PER ORDER (CU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/23/2023
• Initial Date Manufacturer Received: 09/23/2023
• Initial Date FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: # 25 25231 IMPLANT OSSEOSPEED EV DIA 3.6 MM L: 6 M
• Patient Outcome(s): Required Intervention