MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE; VARIOUS

Catalog Number 37508

Device Problem Difficult To Position (1467)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In this event it was reported that a simplant guide was used to carry out an implant surgery.The guide was placed into the oral cavity and although it was misaligned it fit, thus the dentist prepared the osteotomies and it turned out that all implants on the left side were fenestrating the buccal bone plate.

Manufacturer Narrative

The investigation by the simplant team showed that "the prosthesis information could not easily be matched into the scan images because the dual scan protocol was not followed correctly.The implants in region 4, 5, and 6 were planned relatively close to the cortical bone," which need to be avoided by all means to not compromise the integrity of the bone plate.In addition it turned out that the scan parameters were insufficient, the accuracy of the scan was only 0.18mm into the bone (such as implants 4 and 7) have no certainty of being actually in the bone surface in real life.It can be concluded that the customer did some mistakes in planning the case properly, but these flaws should have been detected by the simplant team and in consequence the dentist needs to be informed that no guarantees could be made about the transfer of the implants.Hence user is able to assess whether he or she wants to proceed under those circumstances.Due to an error this notification was not sent.The team embers in question have been informed of this particular issue and will receive additional training.However, it is recommended to keep the commonly accepted distances to important anatomical areas, i.E.Bone plates and adjacent teeth, and to use the "fenestration" function when planning cases which make potentially affected areas visible.The buccal bone plate was destroyed which required additional steps to solve this issue and the quality management did not work properly.

• Brand Name: SURGIGUIDE GUIDE
• Type of Device: VARIOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt, limburg ; BE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st. ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4374841
• MDR Text Key: 5286947
• Report Number: 3007362683-2014-00002
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113739
• 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: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37508
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other