MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SIMPLANT GUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37502

Device Problems No Pressure (2994); Output Problem (3005)

Patient Problems Incompetent Cervix (1927); Discomfort (2330)

Event Date 12/02/2021

Event Type  Injury  

Event Description

The clinician used a simplant universal guide, for two implant simplant guide order, to create the osteotomy for implants on tooth positions 22 and 23 in combination with the universal surgery kit.The patient complained about discomfort and after a few days the implant was removed.The discomfort symptom disappeared.

Manufacturer Narrative

The investigation results point out that the simplant guide was designed according to specifications based on the approved implant planning by the customer.There is no indication found that the simplant guide could have negative impact on the primary stability of the implant.This event is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

• Brand Name: SIMPLANT GUIDE
• 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 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 13170353
• MDR Text Key: 283315638
• Report Number: 3007362683-2021-00011
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASTRATECH IMPLANT EV 3.0S8 MM OS.
• Patient Outcome(s): Required Intervention