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

Catalog Number 37506

Device Problem Insufficient Information (3190)

Patient Problem Sinus Perforation (2277)

Event Type  Injury  

Manufacturer Narrative

Therefore, because this event resulted in a serious injury, it is reportable per 21 cfr part 803.

Event Description

It was reported that a surgiguide did not match the patient's procedure.Implant placement was only possible for 1 of 6 planned implants.During preparation of the one implant, the drill penetrated the patient's sinus membrane.

• Brand Name: SURGIGUIDE GUIDE
• Type of Device: VARIOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt ; BE
• Manufacturer Contact: helen lewis ; susquehanna commerce center w.; 221 w. philadelphia st., ste. 60; york, PA 17401-0000 ; 7178457511
• MDR Report Key: 4990638
• MDR Text Key: 22727701
• Report Number: 3007362683-2015-00013
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• 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: 12/12/2014
• 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