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 08/30/2023

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.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

This event is for a surgiguide.The doctor states that she anesthetize the patient and did immediate extraction of tooth #9.When they placed the implant in she said just kept spinning.So, they grafted the site and closed it up.The doctor said she believes it should have been 2mm deeper into native bone in order to integrate with the bone.

• 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: 17877775
• MDR Text Key: 325003606
• Report Number: 3007362683-2023-00040
• 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: 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: 09/20/2023
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 26315 ASTRATECH IMPL EV 3.6S 15MM OS
• Patient Outcome(s): Required Intervention