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

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Date 02/10/2024

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The dhr review and the investigation of the digital planning and design file, returned material did not reveal anomalies.  trend is tracked and monitored.

Event Description

In this event with the use of the surgiguide for implantation design of the guide has problems.Implants don't gets in place during placement.Updated information: there is no issue with the design of the guide.The customer complains on the transfer of the implant: the position of the implant 4.2 ps 11 mm is too shallow.I repeated the drill protocol and still the implant is not in correct position, also not manually.He replaced the implant with a 3.6 s 11 mm implant.This implant was in correct position, but there is no primary stability.After 48 hrs the implant 26313: astra tech implant ev 3.6s - 11mm became loose.

• 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: 18846122
• MDR Text Key: 336997249
• Report Number: 3007362683-2024-00001
• 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: 03/06/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2024
• Initial Date Manufacturer Received: 02/10/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2024
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 26373 ASTRA TECH IMPLANT EV PROFILE 4.2 PS- 11 MM