MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 3 IMPLANTS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Device Handling Problem (3265)

Patient Problem Failure of Implant (1924)

Event Date 07/15/2023

Event Type  Injury  

Event Description

It was reported that a patient experienced a dental implant loss.Hg, (b)(6) 2023: as described in case (b)(4) there is additional information received about the first surgery: it was (b)(6) 2023.Implant # 36 was successfully placed with the guide 30216738 , but implants # 46 and # 47 were not placed.The dentist did not continued free handed, no bone grafting necessary.Implants # 46 and # 47 ( both astra 4.8 s 11 mm) were forwarded to the sales rep.For the second guided surgery with the same simplant guide 30216738 on (b)(6) 2023: implant # 46 was successfully placed but implant # 47 has an issue: when placing the implant, the implant it does not lower even manually beneath the soft tissue or the length is not correctly determined by the guide: it remains loose with no primary stability and the implant can be taken out by hand.The problem was the guide because it remains unstable distally with limited mouth opening.(b)(4).After further exchange with the simplant team, information and conclusion is the following: customer originally ordered a guide for tooth position 36 (eu) only, but never used it.Later he ordered a guide for 36, 46 and 47 but conducted the first surgery for 36 only.Also it can be seen on the attached opg that customer placed a profile implant which was against the planning.Also the profile rimp is badly positioned.Case (b)(4) was opened for the first surgery, but as per the above described it does not represent a complaint.Hence (b)(4) will be voided.Case (b)(4) was opened for the second surgery.A fit issue was complained (46,47 was planned to be implanted - only 46 was done successfully).It meanwhile turned out, that the second surgery was conducted after more than 3 month after guide production, which is not allowed.Further and probably due to the not fitting after several months, guide was manipulated by the customer.So (b)(4) will be kept and reported, but is considered not justified.Customer is more hunting for a remake free of charge.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device and the digital planning was evaluated, without having found any issues that can be traced to the product or it's quality.The investigation of the returned product indicates customer's manipulation.Also the product (guide) was used after more than 3 month which is not allowed.( the shelf life is 2 months after manufacture date).

• Brand Name: SURGIGUIDE - 3 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: 17480804
• MDR Text Key: 320606512
• Report Number: 3007362683-2023-00036
• 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: 08/08/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/15/2023
• Initial Date Manufacturer Received: 07/15/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 25244 FOR POSITION # 31/47
• Patient Outcome(s): Required Intervention