MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE; VARIOUS, EBG, LLZ, DZE

Catalog Number 37506

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

In this case, a customer intended to place competitor implants (biohorizon) by using a surgiguide, subsequently after extensively reducing the local bone supported by a simplant reduction guide.However, he was not able to seat the drill guide properly, thus he assumed that the bone was not reduced sufficiently and removed more bone material from the mandible.But still the drill guide did not fit as desired and he suspected that the drills were not able to go deep enough into the bone.He assumed that the guiding tubes were located too high in the guide.

Manufacturer Narrative

The internal inspection revealed that the bone reduction was too voluminous, thus the improper fit of the surgical guide occurred.Therefore, because treatment could not be completed, this event is reportable per 21 cfr part 803.The bad fit of the drill guide is probably caused by the complexity of the reduced area.It would be unlikely that the bone edge during surgery was obtained in the same way as the digital simulation thereof.A replacement order after a new scan will be taken.

• Brand Name: SURGIGUIDE GUIDE
• Type of Device: VARIOUS, EBG, LLZ, DZE
• 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: 4961237
• MDR Text Key: 6254600
• Report Number: 3007362683-2015-00012
• 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: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• 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