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

Catalog Number 37472

Device Problem Malposition of Device (2616)

Patient Problem Sinus Perforation (2277)

Event Type  Injury  

Manufacturer Narrative

The preliminary investigation could only be performed on the digital design files.The customer was warned in the order remarks that the quality of the model didn't meet our quality standards, which could influence the fit of the guide.There are no other remarks indicating any possible issue for implant 4.The preliminary investigation results point out that the simplant guide was designed according to specifications based on the clinical data provided by the customer.Once we receive the product in the manufacturing facility a physical investigation of the product will be conducted.This event is reportable per 21 cfr part 803.

Event Description

The clinician used a simplant safe guide file to create the osteotomy for implants 1, 2, 3, 4, in combination with the astra tech surgery kit.The drill for implant tooth #14 (4), perforated the sinus floor.The simplant guide printed from the simplant guide file was used during the entire procedure.The clinician placed the implant which sealed of the puncture.

• 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: joleta ness ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12112718
• MDR Text Key: 263827423
• Report Number: 3007362683-2021-00004
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention