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 Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Guide planning and production records have been evaluated without findings.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.

Event Description

In this event it is reported that a surgery was done and the surgiguide - 1 implant was a good fit.They followed the azento drilling protocols but when they surgiguide was placed the doctor didn't like the final placement of the implant.The dentist removed the implant and bone grafted the area.The plan is to see the patient in 6 months.

• 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: 19048967
• MDR Text Key: 339431770
• Report Number: 3007362683-2024-00002
• 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: 04/05/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/07/2024
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 26313 ASTRATECH IMPL EV 3.6S 11MM OS