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

Catalog Number 37501

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The products are returned for investigation.The investigation was performed on the digital design files, the returned simplant guide and printed model.The customer was warned that the matching of the tooth model onto the ct images is uncertain and patient or scan movement was noticed, which could result in an incorrect implant transfer.This was mentioned in the order remarks to inform the customer.The customer was also informed that simulating a tooth extraction could influence the fit/stability or implant transfer of the guide.The customer reviewed and approved the implant planning proposal and simplant guide design after reviewing the order remarks.The digital design of the product does not show any abnormalities.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.

Event Description

The clinician used a simplant safe guide to create the osteotomy for implants on tooth position 9 in combination with the astra tech guided surgery kit.The clinician noticed that there was no primary stability, the implant came out with the implant driver during placement.

• 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: 11795560
• MDR Text Key: 249657573
• Report Number: 9612468-2021-06815
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1