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

Catalog Number 37502

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

In this event it was reported that simplant guides were used to carry out an implant surgery.The first guide was placed into the mouth of the patient and the first drill steps were performed, while the assistant held the guide in place by applying pressure onto the anterior teeth.After removing the first guide and placing the drills in the osteotomies the dentist realized that they were canted mesially, and when positioning the second guide a distinct rocking motion antero-posteriorly was noted.This rocking motion was present for all 3 guides.Thus the dentist decided to stop the procedure since he was uncertain about the correct implant transfer.

Manufacturer Narrative

All three (3) guides and the plaster model were investigated by the simplant team.The testing of these guides on the plaster model revealed a distinct rocking motion when applying pressure to either the anterior teeth or to the posterior molar (#30).When no pressure is applied the fit of the guide was good and it was in the correct position.It is recommended to avoid any incorrect fitting clinically to mimic the situation on the plaster model before using the guide.Although the patient was not harmed the surgical intervention was not completed as intended due to malfunction of the product.As such, this event is reportable per 21 cfr part 803.

• Brand Name: SURGIGUIDE GUIDE
• Type of Device: VARIOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt, limburg ; BE
• Manufacturer Contact: helen lewis ; 2221 w. philadelphia st. ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4374842
• MDR Text Key: 5261046
• Report Number: 3007362683-2014-00001
• 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: 08/06/2014

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: 37502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• 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): Required Intervention